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 Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Comparative Safety and Effectiveness of Warfarin, Dabigatran, and Rivaroxaban Among Japanese Patients With Non-valvular Atrial Fibrillation (NVAF) and Concomitant Coronary Artery Disease (CAD)

Conditions
-----------------
Coronary Artery Disease, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Warfarin users<br> | |
| Dabigatran users<br> | |
| Rivaroxaban users<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of fatal or non-fatal major bleeding (defined as any blood transfusion and/or any hospitalization with associated bleeding) in all three patient groups |  | From April 2011 to December 2020, Up to 9 years and 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite outcome of stroke/Systemic Embolism/Myocardial Infarction/all-cause mortality (inpatient) /major bleeding/major Gastrointestinal bleeding (hospitalization due to GI bleeding)/Intracranial Hemorrhage in all three patient groups |  | From April 2011 to December 2020, Up to 9 years and 8 months |