Trial Outcomes & Findings for The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage (NCT NCT02043808)
NCT ID: NCT02043808
Last Updated: 2015-07-03
Results Overview
Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
COMPLETED
25586 participants
From October 1, 2009 through July 31, 2013 (the study period)
2015-07-03
Participant Flow
Existing data cohort design with propensity score matching (PSM). Variables included in the final propensity score model were: age, gender index year, baseline CHADS(2) score, baseline CHA(2)DS(2)-VASc score, baseline HAS-BLED score, baseline use of several medications and presence of several baseline co-morbidities.
Participant milestones
| Measure |
Dabigatran
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Overall Study
STARTED
|
12793
|
12793
|
|
Overall Study
COMPLETED
|
12793
|
12793
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage
Baseline characteristics by cohort
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
Total
n=25586 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
74.0 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
73.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5277 Participants
n=5 Participants
|
5253 Participants
n=7 Participants
|
10530 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7516 Participants
n=5 Participants
|
7540 Participants
n=7 Participants
|
15056 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period)Population: All patients in the post-propensity score matching cohort
Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Stroke (Hemorrhagic, Ischemic)
|
9.15 Events per 1000 person-years
Interval 7.41 to 11.19
|
13.19 Events per 1000 person-years
Interval 10.74 to 16.05
|
PRIMARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period)Population: All patients in the post-propensity score matching cohort
Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major Bleeding
|
30.84 Events per 1000 person-years
Interval 27.55 to 34.42
|
37.04 Events per 1000 person-years
Interval 32.82 to 41.65
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period)Population: All patients in the post-propensity score matching cohort
Event rate of ischemic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Ischemic Stroke
|
8.48 Events per 1000 person-years
Interval 6.8 to 10.45
|
10.69 Events per 1000 person-years
Interval 8.49 to 13.28
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of hemorrhagic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Hemorrhagic Stroke
|
0.77 Events per 1000 person-years
Interval 0.33 to 1.51
|
2.50 Events per 1000 person-years
Interval 1.5 to 3.9
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of major intracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major Intracranial Bleeding
|
2.69 Events per 1000 person-years
Interval 1.79 to 3.88
|
5.65 Events per 1000 person-years
Interval 4.09 to 7.62
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of major extracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major Extracranial Bleeding
|
28.13 Events per 1000 person-years
Interval 24.99 to 31.55
|
31.30 Events per 1000 person-years
Interval 27.44 to 35.56
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of major gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major GI Bleeding
|
25.40 Events per 1000 person-years
Interval 22.42 to 28.66
|
23.69 Events per 1000 person-years
Interval 20.34 to 27.42
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of major upper gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major Upper GI Bleeding
|
5.48 Events per 1000 person-years
Interval 4.15 to 7.1
|
7.63 Events per 1000 person-years
Interval 5.8 to 9.87
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of major lower gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major Lower GI Bleeding
|
20.25 Events per 1000 person-years
Interval 17.6 to 23.18
|
16.38 Events per 1000 person-years
Interval 13.62 to 19.52
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of major urogenital bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major Urogenital Bleeding
|
1.06 Events per 1000 person-years
Interval 0.53 to 1.89
|
3.02 Events per 1000 person-years
Interval 1.92 to 4.54
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of major other bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Major Other Bleeding
|
1.92 Events per 1000 person-years
Interval 1.17 to 2.97
|
5.13 Events per 1000 person-years
Interval 3.65 to 7.01
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of transient ischemic attacks. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Transient Ischemic Attack
|
4.62 Events per 1000 person-years
Interval 3.4 to 6.12
|
5.53 Events per 1000 person-years
Interval 3.99 to 7.48
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of myocardial infarction. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Myocardial Infarction
|
5.09 Events per 1000 person-years
Interval 3.82 to 6.66
|
7.77 Events per 1000 person-years
Interval 5.92 to 10.03
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of venous thromboembolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Venous Thromboembolism
|
1.34 Events per 1000 person-years
Interval 0.73 to 2.25
|
2.10 Events per 1000 person-years
Interval 1.2 to 3.42
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of deep vein thrombosis. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Deep Vein Thrombosis
|
0.58 Events per 1000 person-years
Interval 0.21 to 1.25
|
1.31 Events per 1000 person-years
Interval 0.63 to 2.42
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of pulmonary embolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Pulmonary Embolism
|
0.77 Events per 1000 person-years
Interval 0.33 to 1.51
|
0.79 Events per 1000 person-years
Interval 0.29 to 1.72
|
SECONDARY outcome
Timeframe: From October 1, 2009 through July 31, 2013 (the study period).Population: All patients in the post-propensity score matching cohort
Event rate of death, due to any cause. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Outcome measures
| Measure |
Dabigatran
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
|
Warfarin
n=12793 Participants
Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
|
|---|---|---|
|
Death
|
31.28 Events per 1000 person-years
Interval 27.98 to 34.87
|
52.41 Events per 1000 person-years
Interval 47.4 to 57.82
|
Adverse Events
Dabigatran
Warfarin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER