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

Completed

• Conditions: Coronary Artery Disease; Atrial Fibrillation

• Registration Number: NCT05051904
• Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-21
• Study Start: 2022-05-17
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2023-07
• Results First Submitted: 2023-07-26
• Results First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Results First Posted: 2024-03-07
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39357

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Fatal or Non-fatal Major Bleeding	From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.	Incidence rate of fatal or non-fatal major bleeding per number of person-years, defined as any blood transfusion and/or any hospitalization with associated bleeding in all three patient groups. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000\*person-years)).

Secondary Outcome Measures

Name	Time	Method
Incidence Rate of Composite Outcome of Stroke/SE/MI/All-cause Mortality (Inpatient) /Major Bleeding/Major GI Bleeding/ICH	From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.	Incidence rate of the Composite outcome of stroke/SE/MI/all-cause mortality (inpatient) /major bleeding/major GI bleeding (hospitalization due to gastrointestinal bleeding)/ICH (Intracraneal hemorrhage) per number of person-years. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000\*person-years)). The propensity scores were estimated using the multivariable logistic regression model. Statistical analysis for comparisons: Dabigatran-Warfarin, and Rivaroxaban-Warfarin are presented as per protocol.

Trial Locations

Locations (1)

Boehringer Ingelheim - International GmbH; 🇩🇪 Ingelheim am Rhein, Germany