Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Boehringer Ingelheim

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Warfarin

Drug: Dabigatran

Study type

Observational

Funder types

Industry

Identifiers

NCT03254134

1160-0288

Details and patient eligibility

About

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.

Full 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.

Enrollment

22,490 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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