A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin

Boehringer Ingelheim

Status: Completed

Conditions: Coronary Artery Disease; Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT05051904

1160-0308

Details and patient eligibility

About

The study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD).

Enrollment: 39,357 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-≥18 years of age

• Has one year of look-back period prior to the index date (defined as the first date of prescription for dabigatran, rivaroxaban, or warfarin during the study period)
• New users of warfarin, dabigatran, and rivaroxaban, defined as patients without historic use of any oral anticoagulants during the look-back period
• Has at least 1 diagnosis of NVAF during the look-back period prior to or on the index date
• Has at least 1 diagnosis of CAD during the look-back period prior to or on the index date

Exclusion criteria

• Diagnosed with end-stage renal disease, or undergo hemodialysis, or experience pregnancy during the study period
• Initiate warfarin, dabigatran, rivaroxaban due to valvular Atrial Fibrillation (AF), AF associated with mechanical valve malfunction or mechanical complication of heart valve prosthesis, or rheumatic AF
• Underwent joint replacement procedures or diagnosed with venous thromboembolism during the look-back period prior to or on the index date
• Prescribed with more than 1 oral anticoagulation (OAC) on the index date
• Prescribed with more than 2 anti-platelet drugs per prescription (triple or quadruple anti-platelet use), or prescribed with any anti-platelet injection
• Patients with missing or ambiguous age or sex information

Trial design

39,357 participants in 3 patient groups

Warfarin

Description:

All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

Dabigatran

Description:

All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

Rivaroxaban

Description:

All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).