Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-20

Study Completion Date

2017-11-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Atrial Fibrillation

patients with atrial fibrillation

Warfarin

Intervention Type DRUG

patients treated with warfarin

Dabigatran

Intervention Type DRUG

patients treated with Dabigatran

Interventions

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Warfarin

patients treated with warfarin

Intervention Type DRUG

Dabigatran

patients treated with Dabigatran

Intervention Type DRUG

Other Intervention Names

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PRADAXA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No