N/A
Completed N=39,357
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
Source: ClinicalTrials.gov NCT05051904 ↗Enrolled (actual)
39,357
Serious AEs
—
Results posted
Mar 2024
Primary outcomePrimary: Incidence Rate of Fatal or Non-fatal Major Bleeding — 26; 52; 41; 52 Events per 1,000 person-years — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Fatal or Non-fatal Major Bleeding |
26; 52; 41; 52; 26; 41 | <0.0001 sig |
| SECONDARY Incidence Rate of Composite Outcome of Stroke/SE/MI/All-cause Mortality (Inpatient) /Major Bleeding/Major GI Bleeding/ICH |
213; 275; 228; 275; 213; 228 | <0.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT05051904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.