Status:
COMPLETED
Comparative Effectiveness and Safety Between Warfarin and Dabigatran
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estim...
Detailed Description
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estim...
Eligibility Criteria
Inclusion
- patients aged \>18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)
- having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016
- having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)
Exclusion
- patients having less than 12 months of enrolment prior to the index date
- being dialysis or kidney transplant recipients in baseline period
- having either atrial flutter, valvular atrial fibrillation (AF)
- mechanical valve placement, rheumatic AF
- and/or mitral valve prolapse/regurge/stenosis in baseline period
- having record of deep vein thrombosis or pulmonary embolism \< 6 months before AF diagnosis in baseline period
Key Trial Info
Start Date :
October 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 3 2017
Estimated Enrollment :
22490 Patients enrolled
Trial Details
Trial ID
NCT03254134
Start Date
October 20 2017
End Date
November 3 2017
Last Update
July 9 2019
Active Locations (1)
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1
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, Japan