Comparative Effectiveness and Safety Between Warfarin and Dabigatran
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|ClinicalTrials.gov Identifier: NCT03254134|
Recruitment Status : Completed
First Posted : August 18, 2017
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Drug: Warfarin Drug: Dabigatran|
|Study Type :||Observational|
|Actual Enrollment :||22490 participants|
|Official Title:||Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients|
|Actual Study Start Date :||October 20, 2017|
|Actual Primary Completion Date :||October 30, 2017|
|Actual Study Completion Date :||November 3, 2017|
patients with atrial fibrillation
patients treated with warfarin
patients treated with Dabigatran
Other Name: PRADAXA
- Incidence Rate of Stroke and Systemic Embolism (SE) [ Time Frame: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years. ]Incidence rate of stroke and systemic embolism (SE).
- Incidence Rate of Major Bleeding [ Time Frame: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years. ]Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254134
|Nippon Boehringer Ingelheim Co., Ltd.|