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PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin

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ClinicalTrials.gov Identifier: NCT01227629
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : February 10, 2011
Last Update Posted : May 5, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Prevention
Condition Atrial Fibrillation
Interventions Drug: dabigatran with ASA
Drug: warfarin
Drug: dabigatran without ASA
Enrollment 502
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description bid (twice daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral + qd (once daily) oral qd (once daily) oral
Period Title: Overall Study
Started 58 [1] 20 27 99 34 33 98 33 30 70
Completed 56 [2] 18 26 91 32 32 90 27 24 68
Not Completed 2 2 1 8 2 1 8 6 6 2
Reason Not Completed
Adverse Event             2             2             1             6             1             1             6             6             4             0
Protocol Violation             0             0             0             1             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             1             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             2             0             0             1
Not Specified             0             0             0             1             0             0             0             0             2             1
[1]
Started: Participant was randomised and took at least one dose of randomised study medication
[2]
Completed: Participant without premature discontinuation in the randomised treatment period
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0 Total
Hide Arm/Group Description bid (twice daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral bid (twice daily) oral + qd (once daily) oral bid (twice daily) oral + qd (once daily) oral qd (once daily) oral Total of all reporting groups
Overall Number of Baseline Participants 58 20 27 99 34 33 98 33 30 70 502
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
69.0  (8.8) 70.1  (9.4) 71.6  (8.1) 69.7  (7.7) 72.1  (9.0) 69.7  (8.0) 69.0  (9.1) 71.8  (7.2) 68.6  (7.1) 69.0  (8.3) 69.7  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
Female
12
  20.7%
4
  20.0%
5
  18.5%
15
  15.2%
8
  23.5%
8
  24.2%
19
  19.4%
7
  21.2%
2
   6.7%
11
  15.7%
91
  18.1%
Male
46
  79.3%
16
  80.0%
22
  81.5%
84
  84.8%
26
  76.5%
25
  75.8%
79
  80.6%
26
  78.8%
28
  93.3%
59
  84.3%
411
  81.9%
Baseline documentation regarding the atrial fibrillation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
Persistent 20 9 10 43 13 10 37 14 12 27 195
Permanent 23 9 11 35 11 16 37 10 14 26 192
Paroxysmal 15 2 6 21 10 7 24 9 4 17 115
Baseline documentation regarding stroke   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
No 54 18 24 93 30 30 91 31 26 62 459
Yes 4 2 3 6 4 3 7 2 4 8 43
[1]
Measure Description: Documentation of stroke as specific risk factor
Baseline documentation regarding transient ischemic attack   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
No 49 20 25 88 31 31 90 30 26 63 453
Yes 9 0 2 11 3 2 8 3 4 7 49
[1]
Measure Description: Documentation of transient ischemic attack as specific risk factor
Baseline documentation regarding transient ischemic attack or stroke   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
No 45 18 23 82 27 28 85 28 22 57 415
Yes 13 2 4 17 7 5 13 5 8 13 87
[1]
Measure Description: Documentation of transient ischemic attack or stroke as specific risk factor
Baseline documentation regarding hypertension   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
No 17 10 8 21 13 14 24 8 10 21 146
Yes 41 10 19 78 21 19 74 25 20 49 356
[1]
Measure Description: Documentation of hypertension as specific risk factor
Baseline documentation regarding symptomatic heart failure   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
No 41 12 17 73 20 21 85 20 20 46 355
Yes 17 8 10 26 14 12 13 13 10 24 147
[1]
Measure Description: Documentation of symptomatic heart failure as specific risk factor
Baseline documentation regarding left ventricular dysfunction   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
No 41 14 17 68 22 19 78 20 14 44 337
Yes 17 6 10 31 12 14 20 13 16 26 165
[1]
Measure Description: Documentation of left ventricular dysfunction as specific risk factor
Baseline documentation regarding symptomatic heart failure or left ventricular dysfunction   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
No 35 10 14 55 15 17 71 14 12 34 277
Yes 23 10 13 44 19 16 27 19 18 36 225
[1]
Measure Description: Documentation of symptomatic heart failure or left ventricular dysfunction as specific risk factor
Coronary Artery Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
no 39 1 1 55 3 4 62 2 1 28 196
yes 19 19 26 44 31 29 36 31 29 42 306
[1]
Measure Description: Documentation of Coronary Artery Disease as inclusion criterion or specific risk factor
D-dimer at baseline N=(56;19;25;88;29;32;85;31;29;63;457)  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
106.8  (104.1) 104.5  (62.9) 176.9  (389.9) 100.8  (94.5) 120.3  (95.4) 96.3  (64.3) 146.8  (210.9) 119.4  (95.5) 83.8  (48.8) 139.9  (251.9) 120.9  (173.7)
Soluble fibrin at baseline N=(53;16;23;88;27;29;92;30;25;65;448)  
Mean (Standard Deviation)
Unit of measure:  µg/ml
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
4.9  (4.4) 5.3  (7.9) 5.4  (5.9) 5.8  (8.8) 9.1  (15.5) 7.6  (14.8) 7.4  (11.5) 9.2  (26.0) 6.5  (9.2) 7.2  (10.4) 6.8  (11.9)
Thromboxane B2 (TXB2) measured at baseline N=(53;20;23;93;30;30;90;31;30;67;467)  
Mean (Standard Deviation)
Unit of measure:  Pg/mg Creatinine
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
3968.5  (2530.4) 3795.9  (2252.9) 4705.6  (3047.5) 4138.1  (2184.6) 4485.7  (2147.8) 4084.9  (2253.5) 3619.0  (2020.6) 4450.8  (2653.7) 3735.6  (2440.6) 4177.9  (2661.2) 4051.6  (2367.7)
ECT at baseline N=(57;20;27;98;34;33;95;33;29;56;482)  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
32.3  (2.0) 31.8  (1.9) 31.9  (2.2) 31.9  (2.2) 32.0  (1.9) 32.6  (2.4) 33.6  (13.3) 31.9  (1.8) 32.2  (2.6) 32.0  (2.4) 32.4  (6.2)
aPTT at baseline N=(57;20;27;98;34;33;96;33;29;57;484)  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 58 participants 20 participants 27 participants 99 participants 34 participants 33 participants 98 participants 33 participants 30 participants 70 participants 502 participants
32.5  (3.0) 31.2  (3.5) 32.4  (3.6) 34.2  (15.2) 33.5  (7.6) 34.2  (6.7) 32.8  (5.7) 32.6  (3.4) 32.9  (6.7) 33.2  (3.7) 33.1  (8.2)
1.Primary Outcome
Title Number of Participants With Fatal or Life-threatening Major Bleeding Events
Hide Description Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 59 21 27 100 36 33 105 34 30 70
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 1 3 0
2.Primary Outcome
Title Number of Participants With Minor/Relevant Bleeding Events
Hide Description Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons were performed, due to the small number of events per group
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 59 21 27 100 36 33 105 34 30 70
Measure Type: Number
Unit of Measure: Participants
0 1 1 9 2 2 6 4 3 4
3.Primary Outcome
Title Number of Participants With Minor/Nuisance Bleeding Events
Hide Description All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons were performed, due to the small number of events per group
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 59 21 27 100 36 33 105 34 30 70
Measure Type: Number
Unit of Measure: Participants
2 1 2 6 6 5 9 7 9 9
4.Secondary Outcome
Title Number of Participants With Thromboembolic Events: Composite Endpoint
Hide Description Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
1 2 1 0 0 0 0 0 0 0
5.Secondary Outcome
Title Number of Participants With Thromboembolic Events: Ischemic Stroke
Hide Description Occurence of an ischemic stroke (fatal or non-fatal)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
None 58 19 27 99 34 33 98 33 30 70
Fatal 0 0 0 0 0 0 0 0 0 0
Non-Fatal 0 1 0 0 0 0 0 0 0 0
Both 0 0 0 0 0 0 0 0 0 0
6.Secondary Outcome
Title Thromboembolic Events: Number of Participants With Transient Ischemic Attack
Hide Description Occurence of a transient ischemic attack
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0 0 0
7.Secondary Outcome
Title Thromboembolic Events: Number of Participants With Systemic Thromboembolism
Hide Description Occurence of a systemic thromboembolism
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
1 1 0 0 0 0 0 0 0 0
8.Secondary Outcome
Title Thromboembolic Events: Number of Participants With Myocardial Infarction
Hide Description Occurence of a myocardial infarction
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
None 58 20 27 99 34 33 98 33 30 70
Fatal 0 0 0 0 0 0 0 0 0 0
Non-Fatal 0 0 0 0 0 0 0 0 0 0
Both 0 0 0 0 0 0 0 0 0 0
9.Secondary Outcome
Title Thromboembolic Events: Number of Participants With Other Major Cardiac Events
Hide Description Occurence of other major adverse cardiac events
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
0 1 1 0 0 0 0 0 0 0
10.Secondary Outcome
Title Thromboembolic Events: Number of Participants Who Died
Hide Description Occurence of death by all causes
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0 0 0
11.Secondary Outcome
Title D-dimer: Difference From Baseline
Hide Description Difference in D-dimer from baseline to last available value
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients, only per-protocol data included.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 55 19 26 87 29 32 88 29 29 63
Mean (Standard Deviation)
Unit of Measure: ng/ml
22.3  (65.4) 12.3  (25.3) 50.2  (182.8) 8.1  (41.6) 29.1  (90.4) 8.6  (49.2) 4.2  (95.8) 11.3  (82.2) -7.9  (40.9) -5.8  (50.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIBR 1048 50 mg b.i.d, BIBR 1048 50 mg b.i.d + ASA 81 mg q.d., BIBR 1048 50 mg b.i.d + ASA 325 mg qd, BIBR 1048 150 mg b.i.d, BIBR 1048 150 mg b.i.d + ASA 81 mg qd, BIBR 1048 150 mg b.i.d + ASA 325 mg qd, BIBR 1048 300 mg b.i.d, BIBR 1048 300 mg b.i.d + ASA 81 mg qd, BIBR 1048 300 mg b.i.d + ASA 325 mg qd, Warfarin, Dosed to Target INR 2.0 to 3.0
Comments Group comparison of differences from baseline to last available value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0357
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
12.Secondary Outcome
Title Soluble Fibrin: Difference From Baseline
Hide Description Difference from baseline to visit 7
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients, only per-protocol data included.
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 52 15 25 88 25 24 83 27 20 54
Mean (Standard Deviation)
Unit of Measure: µg/ml
3.2  (22.0) 0.9  (2.3) 1.2  (8.4) 0.3  (5.1) -2.0  (9.9) -1.3  (8.8) 2.3  (26.8) -0.7  (4.6) -1.9  (12.0) 0.1  (4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIBR 1048 50 mg b.i.d, BIBR 1048 50 mg b.i.d + ASA 81 mg q.d., BIBR 1048 50 mg b.i.d + ASA 325 mg qd, BIBR 1048 150 mg b.i.d, BIBR 1048 150 mg b.i.d + ASA 81 mg qd, BIBR 1048 150 mg b.i.d + ASA 325 mg qd, BIBR 1048 300 mg b.i.d, BIBR 1048 300 mg b.i.d + ASA 81 mg qd, BIBR 1048 300 mg b.i.d + ASA 325 mg qd, Warfarin, Dosed to Target INR 2.0 to 3.0
Comments Group comparison of differences from baseline to week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26711
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
13.Secondary Outcome
Title 11-dehydrothromboxane B2 (TXB2): Difference From Baseline
Hide Description Difference from baseline to visit 7
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons due to high variability
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 44 17 19 73 25 27 73 25 25 51
Mean (Standard Deviation)
Unit of Measure: pg/mg Creatinine
596.5  (2896.3) -1816.8  (2186.1) -2779.8  (2953.3) 922.0  (3874.0) -1988.6  (2187.5) -1125.9  (3566.6) 1059.7  (2216.8) -1822.6  (2381.7) -1337.8  (2279.2) 203.5  (2109.0)
14.Secondary Outcome
Title Ecarin Clotting Time (ECT): Difference From Baseline
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons due to high variability
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 56 19 26 94 34 33 86 29 27 27
Mean (Standard Deviation)
Unit of Measure: seconds
9.7  (8.2) 12.0  (10.7) 12.0  (9.6) 31.9  (26.2) 42.5  (29.2) 32.7  (23.1) 63.6  (44.8) 70.8  (60.3) 74.0  (70.5) 3.1  (2.5)
15.Secondary Outcome
Title Activated Partial Thromboplastin Time (aPTT): Difference From Baseline
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons due to high variability
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 56 19 26 92 33 33 87 29 27 27
Mean (Standard Deviation)
Unit of Measure: seconds
6.4  (5.6) 8.3  (6.1) 8.8  (9.4) 13.5  (18.3) 24.9  (26.1) 14.5  (11.5) 25.0  (12.4) 23.4  (12.7) 27.2  (24.2) 8.8  (6.7)
16.Secondary Outcome
Title Trough Plasma Concentration of Dabigatran (BIBR 953)
Hide Description The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 97 33 30 70
Mean (Standard Deviation)
Unit of Measure: ng/ml
29.1  (16.6) 30.4  (16.6) 31.8  (20.0) 82.8  (54.3) 103.2  (69.0) 90.1  (52.5) 188.0  (117.3) 203.7  (123.9) 207.6  (108.7) NA  (NA)
17.Secondary Outcome
Title Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline
Hide Description Increase of AST to more than two times the baseline value
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons due to extremely small number of cases
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
Missing 0 0 0 0 0 0 1 1 0 1
No 57 20 24 93 32 31 95 31 30 68
Yes 1 0 3 6 2 2 2 1 0 1
18.Secondary Outcome
Title Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline
Hide Description Increase of AP to more than two times the baseline value
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons due to extremely small number of cases
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
Missing 0 0 0 0 0 0 1 1 0 1
No 58 20 27 98 33 33 97 32 29 69
Yes 0 0 0 1 1 0 0 0 1 0
19.Secondary Outcome
Title Number of Participants With Increase of Bilirubin to >2*Baseline
Hide Description Increase of Bilirubin to more than two times the baseline value
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons due to extremely small number of cases
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
Missing 0 0 0 0 0 0 1 1 0 1
No 55 18 25 86 31 33 88 29 29 63
Yes 3 2 2 13 3 0 9 3 1 6
20.Secondary Outcome
Title Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline
Hide Description Number of Participants with Increase of ALT to more than two times the baseline value
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. No statistical comparisons due to extremely small number of cases
Arm/Group Title BIBR 1048 50 mg b.i.d BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. BIBR 1048 50 mg b.i.d + ASA 325 mg qd BIBR 1048 150 mg b.i.d BIBR 1048 150 mg b.i.d + ASA 81 mg qd BIBR 1048 150 mg b.i.d + ASA 325 mg qd BIBR 1048 300 mg b.i.d BIBR 1048 300 mg b.i.d + ASA 81 mg qd BIBR 1048 300 mg b.i.d + ASA 325 mg qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral
bid (twice daily) oral + qd (once daily) oral
bid (twice daily) oral + qd (once daily) oral
qd (once daily) oral
Overall Number of Participants Analyzed 58 20 27 99 34 33 98 33 30 70
Measure Type: Number
Unit of Measure: Participants
Missing 0 0 0 0 0 0 1 1 0 1
No 55 18 26 95 33 32 93 31 30 64
Yes 3 2 1 4 1 1 4 1 0 5
21.Secondary Outcome
Title Severity of Adverse Events
Hide Description Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients(Numbers of patients for adverse events are counted for each treatment and are in their sum greater than the total number of patients randomized as 14 patients on Dabigatran with ASA changed treatment,12 patients down titrated Dabigatran bid to qd of which one did the down titration at the same time as the stop of the ASA treatment)
Arm/Group Title D50bid D50qd D50bid + ASA81qd D50bid + ASA325qd D150bid D150qd D150bid + ASA81qd D150qd + ASA81qd D150bid + ASA325qd D150qd + ASA325qd D300bid D300qd D300bid + ASA81qd D300qd + ASA81qd D300bid + ASA325qd D300qd + ASA325qd Warfarin, Dosed to Target INR 2.0 to 3.0
Hide Arm/Group Description:
Dabigatran 50 mg twice daily
Dabigatran 50 mg once daily
Dabigatran 50 mg twice daily + ASA 81 mg once daily
Dabigatran 50 mg twice daily + ASA 325 mg once daily
Dabigatran 150 mg twice daily
Dabigatran 150 mg once daily
Dabigatran 150 mg twice daily + ASA 81 mg once daily
Dabigatran 150 mg once daily + ASA 81 mg once daily
Dabigatran 150 mg twice daily + ASA 325 mg once daily
Dabigatran 150 mg once daily + ASA 325 mg once daily
Dabigatran 300 mg twice daily
Dabigatran 300 mg once daily
Dabigatran 300 mg twice daily + ASA 81 mg once daily
Dabigatran 300 mg once daily + ASA 81 mg once daily
Dabigatran 300 mg twice daily + ASA 325 mg once daily
Dabigatran 300 mg once daily + ASA 325 mg once daily
Warfarin once daily
Overall Number of Participants Analyzed 59 1 21 27 100 3 36 1 33 1 105 3 34 2 30 1 70
Measure Type: Number
Unit of Measure: participants
Mild 24 0 9 16 54 1 23 0 17 0 47 1 23 2 23 1 30
Moderate 13 0 6 7 19 0 9 0 4 0 23 0 5 1 11 1 14
Severe 3 0 1 1 4 0 2 0 1 0 6 0 1 0 2 0 2
Time Frame 12 weeks
Adverse Event Reporting Description Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
 
Arm/Group Title D50bid D50qd D50bid + ASA81qd D50bid + ASA325qd D150bid D150qd D150bid + ASA81qd D150qd + ASA81qd D150bid + ASA325qd D150qd + ASA325qd D300bid D300qd D300bid + ASA81qd D300qd + ASA81qd D300bid + ASA325qd D300qd + ASA325qd Warfarin
Hide Arm/Group Description Dabigatran 50 mg twice daily Dabigatran 50 mg once daily Dabigatran 50 mg twice daily + ASA 81 mg once daily Dabigatran 50 mg twice daily + ASA 325 mg once daily Dabigatran 150 mg twice daily Dabigatran 150 mg once daily Dabigatran 150 mg twice daily + ASA 81 mg once daily Dabigatran 150 mg once daily + ASA 81 mg once daily Dabigatran 150 mg twice daily + ASA 325 mg once daily Dabigatran 150 mg once daily + ASA 325 mg once daily Dabigatran 300 mg twice daily Dabigatran 300 mg once daily Dabigatran 300 mg twice daily + ASA 81 mg once daily Dabigatran 300 mg once daily + ASA 81 mg once daily Dabigatran 300 mg twice daily + ASA 325 mg once daily Dabigatran 300 mg once daily + ASA 325 mg once daily Warfarin once daily
All-Cause Mortality
D50bid D50qd D50bid + ASA81qd D50bid + ASA325qd D150bid D150qd D150bid + ASA81qd D150qd + ASA81qd D150bid + ASA325qd D150qd + ASA325qd D300bid D300qd D300bid + ASA81qd D300qd + ASA81qd D300bid + ASA325qd D300qd + ASA325qd Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
D50bid D50qd D50bid + ASA81qd D50bid + ASA325qd D150bid D150qd D150bid + ASA81qd D150qd + ASA81qd D150bid + ASA325qd D150qd + ASA325qd D300bid D300qd D300bid + ASA81qd D300qd + ASA81qd D300bid + ASA325qd D300qd + ASA325qd Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/59 (8.47%)   0/1 (0.00%)   2/21 (9.52%)   1/27 (3.70%)   10/100 (10.00%)   0/3 (0.00%)   4/36 (11.11%)   0/1 (0.00%)   2/33 (6.06%)   0/1 (0.00%)   3/105 (2.86%)   0/3 (0.00%)   4/34 (11.76%)   0/2 (0.00%)   4/30 (13.33%)   0/1 (0.00%)   2/70 (2.86%) 
Cardiac disorders                                   
Acute coronary syndrome  1  0/59 (0.00%)  0/1 (0.00%)  1/21 (4.76%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Angina pectoris  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Atrial fibrillation  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  1/70 (1.43%) 
Atrial thrombosis  1  0/59 (0.00%)  0/1 (0.00%)  1/21 (4.76%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Cardiac failure  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Cardiac failure congestive  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Ventricular fibrillation  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Ventricular tachycardia  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Gastrointestinal disorders                                   
Abdominal pain  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Dyspepsia  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Gastric ulcer  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Gastrointestinal haemorrhage  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Ileus  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  1/27 (3.70%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Oesophageal ulcer  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Pancreatitis  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Rectal haemorrhage  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
General disorders                                   
Asthenia  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Chest pain  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Hepatobiliary disorders                                   
Cholecystitis  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Cholelithiasis  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Infections and infestations                                   
Diverticulitis  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Pneumonia  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  2/100 (2.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Urinary tract infection  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Injury, poisoning and procedural complications                                   
Implantable defibrillator malfunction  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Radius fracture  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  1/70 (1.43%) 
Investigations                                   
Alanine aminotransferase increased  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Blood pressure systolic inspiratory decreased  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Metabolism and nutrition disorders                                   
Hypokalaemia  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Musculoskeletal and connective tissue disorders                                   
Neck pain  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Pain in extremity  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                   
Basal cell carcinoma  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  2/100 (2.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Colon cancer  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Nervous system disorders                                   
Cerebrovascular accident  1  0/59 (0.00%)  0/1 (0.00%)  1/21 (4.76%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Epilepsy  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Paraesthesia  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Syncope  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Renal and urinary disorders                                   
Renal infarct  1  0/59 (0.00%)  0/1 (0.00%)  1/21 (4.76%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders                                   
Dyspnoea  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Respiratory distress  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Skin and subcutaneous tissue disorders                                   
Skin discolouration  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Surgical and medical procedures                                   
Hip arthroplasty  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Vascular disorders                                   
Circulatory collapse  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Hypotension  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Peripheral embolism  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
D50bid D50qd D50bid + ASA81qd D50bid + ASA325qd D150bid D150qd D150bid + ASA81qd D150qd + ASA81qd D150bid + ASA325qd D150qd + ASA325qd D300bid D300qd D300bid + ASA81qd D300qd + ASA81qd D300bid + ASA325qd D300qd + ASA325qd Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/59 (33.90%)   0/1 (0.00%)   9/21 (42.86%)   14/27 (51.85%)   43/100 (43.00%)   1/3 (33.33%)   19/36 (52.78%)   0/1 (0.00%)   15/33 (45.45%)   0/1 (0.00%)   35/105 (33.33%)   1/3 (33.33%)   20/34 (58.82%)   2/2 (100.00%)   18/30 (60.00%)   1/1 (100.00%)   22/70 (31.43%) 
Cardiac disorders                                   
Angina pectoris  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  1/27 (3.70%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  2/34 (5.88%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  1/70 (1.43%) 
Eye disorders                                   
Conjunctival haemorrhage  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Eye haemorrhage  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  2/105 (1.90%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Gastrointestinal disorders                                   
Abdominal distension  1  1/59 (1.69%)  0/1 (0.00%)  2/21 (9.52%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  1/1 (100.00%)  0/70 (0.00%) 
Abdominal pain  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  2/105 (1.90%)  0/3 (0.00%)  0/34 (0.00%)  1/2 (50.00%)  0/30 (0.00%)  0/1 (0.00%)  1/70 (1.43%) 
Abdominal pain upper  1  2/59 (3.39%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  3/36 (8.33%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Constipation  1  2/59 (3.39%)  0/1 (0.00%)  1/21 (4.76%)  4/27 (14.81%)  0/100 (0.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  2/70 (2.86%) 
Diarrhoea  1  3/59 (5.08%)  0/1 (0.00%)  2/21 (9.52%)  3/27 (11.11%)  3/100 (3.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  2/33 (6.06%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  1/70 (1.43%) 
Dry mouth  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  0/70 (0.00%) 
Dyspepsia  1  1/59 (1.69%)  0/1 (0.00%)  1/21 (4.76%)  1/27 (3.70%)  3/100 (3.00%)  0/3 (0.00%)  3/36 (8.33%)  0/1 (0.00%)  2/33 (6.06%)  0/1 (0.00%)  6/105 (5.71%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  0/70 (0.00%) 
Gingival bleeding  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  1/27 (3.70%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  2/34 (5.88%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Haemorrhoidal haemorrhage  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  1/70 (1.43%) 
Mouth haemorrhage  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  2/34 (5.88%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Nausea  1  2/59 (3.39%)  0/1 (0.00%)  2/21 (9.52%)  0/27 (0.00%)  4/100 (4.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  2/34 (5.88%)  1/2 (50.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Vomiting  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  2/27 (7.41%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  1/2 (50.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
General disorders                                   
Chest pain  1  0/59 (0.00%)  0/1 (0.00%)  2/21 (9.52%)  0/27 (0.00%)  2/100 (2.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  2/34 (5.88%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  1/70 (1.43%) 
Fatigue  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  2/27 (7.41%)  5/100 (5.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  5/34 (14.71%)  1/2 (50.00%)  1/30 (3.33%)  0/1 (0.00%)  3/70 (4.29%) 
Sensation of pressure  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  1/2 (50.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Infections and infestations                                   
Influenza  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  2/34 (5.88%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Nasopharyngitis  1  2/59 (3.39%)  0/1 (0.00%)  0/21 (0.00%)  1/27 (3.70%)  0/100 (0.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Urinary tract infection  1  1/59 (1.69%)  0/1 (0.00%)  1/21 (4.76%)  0/27 (0.00%)  2/100 (2.00%)  1/3 (33.33%)  2/36 (5.56%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  1/70 (1.43%) 
Injury, poisoning and procedural complications                                   
Contusion  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  2/100 (2.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  2/33 (6.06%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  2/34 (5.88%)  0/2 (0.00%)  3/30 (10.00%)  0/1 (0.00%)  6/70 (8.57%) 
Investigations                                   
Alanine aminotransferase increased  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  0/34 (0.00%)  1/2 (50.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Aspartate aminotransferase increased  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  0/34 (0.00%)  1/2 (50.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Musculoskeletal and connective tissue disorders                                   
Back pain  1  0/59 (0.00%)  0/1 (0.00%)  2/21 (9.52%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  2/70 (2.86%) 
Costochondritis  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  1/2 (50.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Pain in extremity  1  2/59 (3.39%)  0/1 (0.00%)  2/21 (9.52%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Nervous system disorders                                   
Dizziness  1  3/59 (5.08%)  0/1 (0.00%)  1/21 (4.76%)  3/27 (11.11%)  4/100 (4.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  4/105 (3.81%)  0/3 (0.00%)  2/34 (5.88%)  1/2 (50.00%)  5/30 (16.67%)  1/1 (100.00%)  2/70 (2.86%) 
Headache  1  2/59 (3.39%)  0/1 (0.00%)  1/21 (4.76%)  4/27 (14.81%)  2/100 (2.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  2/70 (2.86%) 
Renal and urinary disorders                                   
Haematuria  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  7/100 (7.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  2/105 (1.90%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  1/30 (3.33%)  0/1 (0.00%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders                                   
Cough  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  3/100 (3.00%)  0/3 (0.00%)  3/36 (8.33%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  3/105 (2.86%)  0/3 (0.00%)  1/34 (2.94%)  1/2 (50.00%)  1/30 (3.33%)  0/1 (0.00%)  1/70 (1.43%) 
Dyspnoea  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  1/27 (3.70%)  4/100 (4.00%)  0/3 (0.00%)  2/36 (5.56%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  2/105 (1.90%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  1/70 (1.43%) 
Epistaxis  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/100 (1.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  4/105 (3.81%)  0/3 (0.00%)  2/34 (5.88%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  5/70 (7.14%) 
Skin and subcutaneous tissue disorders                                   
Ecchymosis  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  2/33 (6.06%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  2/70 (2.86%) 
Exanthem  1  0/59 (0.00%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  0/100 (0.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  1/3 (33.33%)  0/34 (0.00%)  0/2 (0.00%)  0/30 (0.00%)  0/1 (0.00%)  0/70 (0.00%) 
Vascular disorders                                   
Haematoma  1  1/59 (1.69%)  0/1 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  2/100 (2.00%)  0/3 (0.00%)  1/36 (2.78%)  0/1 (0.00%)  1/33 (3.03%)  0/1 (0.00%)  1/105 (0.95%)  0/3 (0.00%)  1/34 (2.94%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  0/70 (0.00%) 
Hypertension  1  1/59 (1.69%)  0/1 (0.00%)  1/21 (4.76%)  0/27 (0.00%)  5/100 (5.00%)  0/3 (0.00%)  0/36 (0.00%)  0/1 (0.00%)  0/33 (0.00%)  0/1 (0.00%)  0/105 (0.00%)  0/3 (0.00%)  0/34 (0.00%)  0/2 (0.00%)  2/30 (6.67%)  0/1 (0.00%)  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 7.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01227629     History of Changes
Other Study ID Numbers: 1160.20
PETRO trial ( Other Identifier: OTHER )
First Submitted: October 22, 2010
First Posted: October 25, 2010
Results First Submitted: November 18, 2010
Results First Posted: February 10, 2011
Last Update Posted: May 5, 2014