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 Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Warfarin users
|
|
| Dabigatran users
|
|
| Rivaroxaban users
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim - International GmbH | Ingelheim am Rhein | Germany | 55216 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1160-0308