Clinical trial NCT05051904: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 39357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients with non-valvular atrial fibrillation and concomitant coronary artery disease

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).


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

Primary outcomes:
measure: Incidence Rate of Fatal or Non-fatal Major Bleeding
timeFrame: 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.
Secondary outcomes:
measure: Incidence Rate of Composite Outcome of Stroke/SE/MI/All-cause Mortality (Inpatient) /Major Bleeding/Major GI Bleeding/ICH
timeFrame: 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.
Other outcomes:
Locations:
city: Ingelheim am Rhein
country: Germany
facility: Boehringer Ingelheim - International GmbH
Study officials:
References: