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

NCT05051904 | Completed Results

• 1 other identifier: 1160-0308
• Study Type: observational
• Target: 39,357
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Fatal or Non-fatal Major Bleeding

  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)).

  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 (1)

• 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.

Study Arms (3)

Warfarin

All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

Dabigatran

All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

Rivaroxaban

All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Japanese patients with non-valvular atrial fibrillation and concomitant coronary artery disease

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim - International GmbH

Ingelheim, 55216, Germany

Location

Related Publications (1)

• Chen Y, Gong X, Bao H. Real-world clinical outcomes of oral anticoagulants among Japanese patients with atrial fibrillation and concomitant coronary artery disease. Int J Cardiol Heart Vasc. 2023 Nov 2;49:101285. doi: 10.1016/j.ijcha.2023.101285. eCollection 2023 Dec.

  PMID: 38020057 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a Non interventional study (NIS) based on existing data. Therefore, the study might be subject to potential residual confounding due to the absence of certain key data.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 21, 2021
• Study Start: May 17, 2022
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: March 7, 2024
• Results First Posted: March 7, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)