Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Warfarin; Drug: Dabigatran

• Registration Number: NCT03254134
• Lead Sponsor: Boehringer Ingelheim

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 estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

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 estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-18
• Study Start: 2017-10-20
• Primary Completion: 2017-10-30
• Study Completion: 2017-11-03
• Results First Submitted: 2018-10-30
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-04
• Last Update Submitted: 2019-07-04
• Results First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22490

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial Fibrillation	Warfarin	patients with atrial fibrillation
Atrial Fibrillation	Dabigatran	patients with atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Stroke and Systemic Embolism (SE)	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).

Secondary Outcome Measures

Name	Time	Method
Incidence Rate of Major Bleeding	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.

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.; 🇯🇵 Tokyo, Japan