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A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00787150
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : March 6, 2013
Last Update Posted : May 1, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Interventions Drug: Apixaban
Drug: Warfarin sodium
Enrollment 222
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks. One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Period Title: Overall Study
Started 75 [1] 72 [1] 71 [1]
Completed 66 65 66
Not Completed 9 7 5
Reason Not Completed
Adverse Event             4             4             4
Physician Decision             1             2             1
Withdrawal by Subject             2             1             0
Dosing incorrect study durg             2             0             0
[1]
Of 222 participants enrolled 4 discontinued before dosing, made a total of 218 participants started.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID Total
Hide Arm/Group Description The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks. One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 74 74 74 222
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 74 participants 222 participants
71.7  (7.0) 69.3  (8.4) 70.0  (8.1) 70.3  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 74 participants 222 participants
Female
14
  18.9%
11
  14.9%
13
  17.6%
38
  17.1%
Male
60
  81.1%
63
  85.1%
61
  82.4%
184
  82.9%
1.Primary Outcome
Title Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
Hide Description Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 75 72 71
Measure Type: Number
Unit of Measure: participants
4 1 1
2.Secondary Outcome
Title Number of Participants With Total Bleeding Events During the Treatment Period
Hide Description Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 75 72 71
Measure Type: Number
Unit of Measure: participants
13 9 17
3.Secondary Outcome
Title Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period
Hide Description Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 75 72 71
Measure Type: Number
Unit of Measure: participants
1 0 0
4.Secondary Outcome
Title Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period
Hide Description Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 75 72 71
Measure Type: Number
Unit of Measure: participants
3 1 1
5.Secondary Outcome
Title Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period
Hide Description The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 74 74 74
Measure Type: Number
Unit of Measure: participants
3 0 0
6.Secondary Outcome
Title Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period
Hide Description The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 74 74 74
Measure Type: Number
Unit of Measure: participants
3 0 0
7.Secondary Outcome
Title Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period
Hide Description The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 74 74 74
Measure Type: Number
Unit of Measure: participants
0 0 0
8.Other Pre-specified Outcome
Title Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
Hide Description Sample at 4 hours postdose was to be taken if possible.
Time Frame 0, 2, 4 hours postdose at Week 1 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Arm/Group Title Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 72 71
Mean (Standard Deviation)
Unit of Measure: ng/mL
0 hour post dose at Week 1 (n=68, 70) 53.31  (28.55) 119.34  (50.83)
2 hours post dose at Week 1 (n=68, 70) 99.43  (44.65) 201.80  (95.58)
4 hours post dose at Week 1 (n=38, 35) 104.09  (44.48) 224.40  (77.06)
0 hour post dose at Week 8 (n=67, 66) 62.83  (37.27) 137.79  (54.91)
2 hours post dose at Week 8 (n=67, 66) 120.16  (57.79) 250.53  (81.35)
4 hours post dose at Week 8 (n=35, 29) 110.58  (49.96) 244.55  (84.27)
9.Other Pre-specified Outcome
Title Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
Hide Description Sample at 4 hours postdose was to be taken if possible.
Time Frame Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Arm/Group Title Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 72 71
Mean (Standard Deviation)
Unit of Measure: second
Week 0 (n=72, 71) 14.54  (2.20) 14.41  (2.06)
0 hour post dose at Week 1 (n=67, 70) 12.22  (1.56) 12.54  (0.79)
2 hours post dose at Week 1 (n=68, 70) 12.46  (0.72) 13.28  (1.05)
4 hours post dose at Week 1 (n=38, 35) 12.36  (0.67) 13.48  (0.82)
0 hour post dose at Week 8 (n=67, 66) 12.09  (0.73) 12.74  (0.87)
2 hours post dose at Week 8 (n=67, 66) 12.68  (0.82) 13.83  (1.03)
4 hours post dose at Week 8 (n=35, 29) 12.47  (0.75) 13.85  (1.07)
10.Other Pre-specified Outcome
Title Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
Hide Description Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.
Time Frame Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Arm/Group Title Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 72 71
Mean (Standard Deviation)
Unit of Measure: International normalized ratio
Week 0 (n=72, 71) 1.76  (0.46) 1.72  (0.43)
0 hour post dose at Week 1 (n=67, 70) 1.30  (0.37) 1.34  (0.15)
2 hours post dose at Week 1 (n=68, 70) 1.33  (0.14) 1.48  (0.21)
4 hours post dose at Week 1 (n=38, 35) 1.30  (0.12) 1.51  (0.18)
0 hour post dose at Week 8 (n=67, 66) 1.27  (0.14) 1.38  (0.17)
2 hours post dose at Week 8 (n=67, 66) 1.37  (0.16) 1.61  (0.20)
4 hours post dose at Week 8 (n=35, 29) 1.34  (0.15) 1.59  (0.22)
11.Other Pre-specified Outcome
Title Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
Hide Description Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.
Time Frame Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Arm/Group Title Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 72 71
Mean (Standard Deviation)
Unit of Measure: Second
Week 0 (n=72, 71) 34.51  (5.05) 32.98  (4.39)
0 hour post dose at Week 1 (n=67, 70) 33.26  (10.24) 33.24  (4.28)
2 hours post dose at Week 1 (n=68, 70) 33.04  (3.57) 35.19  (4.42)
4 hours oist dose at Week 1 (n=38, 35) 32.00  (3.49) 35.36  (5.44)
0 hour post dose at Week 8 (n=67, 66) 33.83  (5.18) 35.65  (4.32)
2 hours post dose at Week 8 (n=67, 66) 34.67  (4.39) 37.92  (4.78)
4 hours post dose at Week 8 (n=35, 29) 32.75  (3.86) 36.46  (5.19)
12.Other Pre-specified Outcome
Title Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
Hide Description Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.
Time Frame Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Arm/Group Title Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 72 71
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 0 (n=72, 71) 0  (0) 0  (0)
0 hour post dose at Week 1 (n=68, 69) 45.29  (26.77) 111.19  (49.02)
2 hours post dose at Week 1 (n=68, 70) 94.90  (45.23) 187.58  (85.72)
4 hours post dose at Week 1 (n=38, 35) 99.07  (44.46) 213.24  (67.54)
0 hour post dose at Week 8 (n=67, 65) 56.81  (37.34) 130.12  (52.20)
2 hours post dose at Week 8 (n=67, 66) 114.97  (56.25) 236.36  (88.08)
4 hours post dose at Week 8 (n=35, 29) 103.61  (44.54) 237.78  (78.58)
13.Other Pre-specified Outcome
Title Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
Hide Description Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.
Time Frame Week 0, Week 1, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 75 72 71
Mean (Standard Deviation)
Unit of Measure: pmol/L
Week 0 (n=75, 72, 71) 144.0  (345.2) 0  (0) 91.4  (115.3)
Week 1 (n=75, 68, 70) 100.4  (139.0) 133.8  (105.5) 137.0  (255.5)
Week 8 (n=68, 67, 66) 0  (0) 152.9  (79.7) 121.1  (56.3)
14.Other Pre-specified Outcome
Title Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
Hide Description Below the limit of quantification (BLQ) was assigned the value 0 for calculation.
Time Frame Week 0, Week 1, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description:
The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Overall Number of Participants Analyzed 75 72 71
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 0 (n=75, 72, 71) 240.4  (333.5) 297.8  (634.6) 196.4  (181.4)
Week 1 (n=75, 68, 70) 245.2  (325.7) 209.9  (202.6) 237.0  (314.3)
Week 8 (n=68, 67, 66) 209.9  (201.1) 227.0  (253.5) 203.5  (190.6)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Hide Arm/Group Description The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks. One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks. One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
All-Cause Mortality
Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/75 (5.33%)   1/72 (1.39%)   5/71 (7.04%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/75 (1.33%)  0/72 (0.00%)  1/71 (1.41%) 
Overdose  1  0/75 (0.00%)  0/72 (0.00%)  1/71 (1.41%) 
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/75 (0.00%)  0/72 (0.00%)  1/71 (1.41%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/75 (0.00%)  0/72 (0.00%)  1/71 (1.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Rectal cancer  1  0/75 (0.00%)  0/72 (0.00%)  1/71 (1.41%) 
Nervous system disorders       
Cerebral infarction  1  2/75 (2.67%)  0/72 (0.00%)  0/71 (0.00%) 
Subarachnoid haemorrhage  1  1/75 (1.33%)  0/72 (0.00%)  0/71 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/75 (0.00%)  0/72 (0.00%)  1/71 (1.41%) 
Vascular disorders       
Arterial stenosis limb  1  0/75 (0.00%)  1/72 (1.39%)  0/71 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Warfarin Apixaban 2.5mg BID Apixaban 5.0 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/75 (22.67%)   24/72 (33.33%)   22/71 (30.99%) 
Cardiac disorders       
Atrial fibrillation  1  0/75 (0.00%)  0/72 (0.00%)  2/71 (2.82%) 
Bradycardia  1  0/75 (0.00%)  2/72 (2.78%)  0/71 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  0/75 (0.00%)  3/72 (4.17%)  1/71 (1.41%) 
General disorders       
Fatigue  1  0/75 (0.00%)  2/72 (2.78%)  1/71 (1.41%) 
Oedema peripheral  1  0/75 (0.00%)  0/72 (0.00%)  2/71 (2.82%) 
Infections and infestations       
Nasopharyngitis  1  7/75 (9.33%)  8/72 (11.11%)  8/71 (11.27%) 
Injury, poisoning and procedural complications       
Contusion  1  1/75 (1.33%)  0/72 (0.00%)  2/71 (2.82%) 
Fall  1  0/75 (0.00%)  0/72 (0.00%)  2/71 (2.82%) 
Investigations       
Blood bilirubin increased  1  0/75 (0.00%)  2/72 (2.78%)  1/71 (1.41%) 
Blood creatine phophkinase increased  1  0/75 (0.00%)  2/72 (2.78%)  2/71 (2.82%) 
Blood urine present  1  4/75 (5.33%)  1/72 (1.39%)  3/71 (4.23%) 
Renal and urinary disorders       
Haematuria  1  1/75 (1.33%)  0/72 (0.00%)  2/71 (2.82%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/75 (0.00%)  2/72 (2.78%)  1/71 (1.41%) 
Epistaxis  1  4/75 (5.33%)  4/72 (5.56%)  4/71 (5.63%) 
Oropharyngeal pain  1  0/75 (0.00%)  2/72 (2.78%)  0/71 (0.00%) 
Vascular disorders       
Blood pressure inadequately controlled  1  2/75 (2.67%)  0/72 (0.00%)  0/71 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00787150     History of Changes
Other Study ID Numbers: B0661003
First Submitted: November 5, 2008
First Posted: November 7, 2008
Results First Submitted: January 29, 2013
Results First Posted: March 6, 2013
Last Update Posted: May 1, 2013