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Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)

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ClinicalTrials.gov Identifier: NCT00623779
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : July 28, 2011
Last Update Posted : March 23, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Persistent or Permanent Non-valvular Atrial Fibrillation
Interventions Drug: AZD0837
Drug: Aspirin
Enrollment 128
Recruitment Details The study population included male and female participants >18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 22 October 2007 to 21 October 2008 at medical clinics in Europe.
Pre-assignment Details For participants treated with Vitamin K Antagonists (VKA) at the time of enrollment, VKA treatment was to be adjusted (and stopped before randomisation) to ensure that INR was below 2.0 at randomisation. If this was not achieved the participant was discontinued from the study.
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description AZD0837 150 mg AZD0837 300 mg Standard Therapy
Period Title: Overall Study
Started 41 42 45
Completed 38 39 44
Not Completed 3 3 1
Reason Not Completed
Adverse Event             1             3             0
Criteria from CSR             2             0             1
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy Total
Hide Arm/Group Description AZD0837 150 mg AZD0837 300 mg Standard Therapy Total of all reporting groups
Overall Number of Baseline Participants 41 42 45 128
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[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 42 participants 45 participants 128 participants
72.5  (8) 71.6  (8.51) 68.8  (9.36) 70  (8.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 45 participants 128 participants
Female
16
  39.0%
16
  38.1%
17
  37.8%
49
  38.3%
Male
25
  61.0%
26
  61.9%
28
  62.2%
79
  61.7%
1.Primary Outcome
Title Premature Discontinuation of Study or Study Drug Due to Any Reason
Hide Description The premature discontinuation of study or study drug due to any reason
Time Frame 28 week (randomisation visit to last follow up visit in study) according to protocols
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 42 45
Measure Type: Number
Unit of Measure: Participants
4 6 3
2.Primary Outcome
Title Premature Discontinuation of Study Drug Due to Any Reason
Hide Description The premature discontinuation of study drug due to any reason
Time Frame 24 weeks (randomisation visit to last treatment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 42 45
Measure Type: Number
Unit of Measure: Participants
3 3 1
3.Primary Outcome
Title Premature Discontinuation of Study Due to Any Reason
Hide Description |The premature discontinuation of study due to any reason
Time Frame 28 weeks (randomisation visit to last follow up visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 42 45
Measure Type: Number
Unit of Measure: Participants
4 4 2
4.Primary Outcome
Title Compliance With Study Drug
Hide Description [(number of doses dispensed-number of doses returned)/number of days between visits]*100
Time Frame 24 weeks (randomisation visit to last treatment visit) according to protocol
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 39 0
Mean (Standard Deviation)
Unit of Measure: Percentage
96.95  (16.503) 99.82  (11.383)
5.Primary Outcome
Title Compliance With Study Visits/Assessments
Hide Description (number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100
Time Frame 28 weeks (randomisation visit to last follow up visit) according to protocol
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 42 45
Mean (Standard Deviation)
Unit of Measure: Percentage
93.3  (15.01) 95.6  (10.45) 97.5  (6.8)
6.Secondary Outcome
Title Bleeding Events
Hide Description Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once
Time Frame 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
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Hide Analysis Population Description
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 41 46
Measure Type: Number
Unit of Measure: Participants
0 5 2
7.Secondary Outcome
Title Change in Creatinine Level
Hide Description Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time Frame 4 weeks according to protocol (randomisation visit to week 4 visit)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 37 40 45
Mean (Standard Deviation)
Unit of Measure: umol/L
6.2  (8.64) 3.6  (13.21) 2.6  (12.90)
8.Secondary Outcome
Title Alanine Aminotransferase (ALAT)
Hide Description Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.
Time Frame 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 41 46
Measure Type: Number
Unit of Measure: Participants
0 0 1
9.Secondary Outcome
Title Bilirubin
Hide Description Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.
Time Frame 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 41 41 46
Measure Type: Number
Unit of Measure: Participants
1 0 0
10.Secondary Outcome
Title Plasma Concentration of AZD0837 (Prodrug)
Hide Description Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
Time Frame 4 weeks after baseline according to protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 24 26 0
Median (Full Range)
Unit of Measure: nmol/L
596.0
(5.0 to 2920.0)
636.0
(18.2 to 5920.0)
11.Secondary Outcome
Title Plasma Concentration of AR-H067637XX (Active Metabolite)
Hide Description Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
Time Frame 4 weeks after baseline according to protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 24 26 0
Median (Full Range)
Unit of Measure: nmol/L
258.5
(5.0 to 539.0)
368.5
(159.0 to 776.0)
12.Secondary Outcome
Title Change in D-Dimer Level
Hide Description Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time Frame 4 weeks according to protocol.(baseline to week 4 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 38 38 43
Median (Full Range)
Unit of Measure: ng/ml
-33.484
(-78.37 to 288.13)
-41.445
(-92.61 to 130.00)
4.853
(-80.12 to 793.56)
13.Secondary Outcome
Title Activated Partial Thromboplastin Time (APTT)
Hide Description Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time Frame 4 weeks according to protocol.(baseline to week 4 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 25 20 0
Median (Full Range)
Unit of Measure: sec
31.74
(-17.8 to 105.8)
51.51
(3.1 to 75.1)
14.Secondary Outcome
Title Ecarin Clotting Time (ECT)
Hide Description Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time Frame 4 weeks according to protocol.(baseline to week 4 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description:
AZD0837 150 mg
AZD0837 300 mg
Standard Therapy
Overall Number of Participants Analyzed 24 18 0
Median (Full Range)
Unit of Measure: sec
125.6
(6 to 274)
179.1
(7 to 341)
Time Frame [Not Specified]
Adverse Event Reporting Description 41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
 
Arm/Group Title AZD0837 150 mg AZD0837 300 mg Standard Therapy
Hide Arm/Group Description AZD0837 150 mg AZD0837 300 mg Standard Therapy
All-Cause Mortality
AZD0837 150 mg AZD0837 300 mg Standard Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD0837 150 mg AZD0837 300 mg Standard Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/41 (4.88%)   3/41 (7.32%)   2/46 (4.35%) 
Cardiac disorders       
Cardiac Failure  1  0/41 (0.00%)  1/41 (2.44%)  0/46 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal Disorder  1  0/41 (0.00%)  0/41 (0.00%)  1/46 (2.17%) 
General disorders       
Drug Intolerance  1  0/41 (0.00%)  1/41 (2.44%)  0/46 (0.00%) 
Metabolism and nutrition disorders       
Podagra  1  0/41 (0.00%)  0/41 (0.00%)  1/46 (2.17%) 
Renal and urinary disorders       
Renal Failure  1  1/41 (2.44%)  0/41 (0.00%)  0/46 (0.00%) 
Vascular disorders       
Hypotension  1  1/41 (2.44%)  0/41 (0.00%)  0/46 (0.00%) 
Deep Vein Thrombosis  1  0/41 (0.00%)  1/41 (2.44%)  0/46 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD0837 150 mg AZD0837 300 mg Standard Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/41 (7.32%)   1/41 (2.44%)   1/46 (2.17%) 
Infections and infestations       
Bronchitis  1  3/41 (7.32%)  1/41 (2.44%)  1/46 (2.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Phone: +44 1509 645895
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00623779     History of Changes
Other Study ID Numbers: D1250C00051
First Submitted: February 15, 2008
First Posted: February 26, 2008
Results First Submitted: June 30, 2011
Results First Posted: July 28, 2011
Last Update Posted: March 23, 2012