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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39357 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-17

Study Completion Date

2022-07-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Coronary Artery Disease Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Warfarin

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).

No interventions assigned to this group

Dabigatran

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).

No interventions assigned to this group

Rivaroxaban

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).

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No