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NOT YET RECRUITING
NCT06866665
NA

Antithrombotic Strategy for AF Patients With High Risk CAD

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

Anticoagulation therapy is recommended for patients with atrial fibrillation (AF) in order to prevent ischemic stroke and systemic embolism. Meanwhile, lifelong antiplatelet therapy is highly recommended to prevent stent thrombosis and further ischemic adverse events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. In this context, in patients with AF undergoing DES implantation, anticoagulation and antiplatelet therapies perform their own unique roles. However, the current guidelines recommend to discontinue this antiplatelet agent beyond 1 year due to an excessive bleeding risk derived from DAT. The Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) emphasized that bleeding risk derived from rivaroxaban-based DAT may outweigh ischemic risk derived from antiplatelet discontinuation in patients with AF and stable coronary artery disease. Furthermore, the recent Edoxaban versus Edoxaban with Antiplatelet Agent in Patients with Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD) trial also demonstrated that edoxaban monotherapy led to a lower net adverse event compared to than edoxaban-based DAT. Although these studies strongly supported the benefit of antiplatelet discontinuation in AF patients with stable coronary artery disease, many physicians still hesitate to discontinue antiplatelet agents even 1 year after DES implantation because of concerns regarding stent thrombosis or subsequent myocardial infarction (MI). This concern is exacerbated in patients with an excessive ischemic risk, such as those who received complex PCI or those with polyvascular disease. To address this disparity between clinical practice and recommendations based on the guidelines, the Adequate Antiplatelet and Anticoagulation Therapy in Atrial Fibrillation Patients with Focus on Ischemic Risk Management (ADAPT AFFIRM) trial is designed to elucidate the efficacy and safety of apixaban monotherapy versus apixaban plus clopidogrel combination therapy as a chronic maintenance strategy in AF patients with stable coronary artery disease and excessive ischemic risk.

Official title: ADequate AntiPlatelet and Anticoagulation Therapy in Atrial Fibrillation Patients With Focus on Ischemic Risk Management A Randomized ADAPT AFFIRM Study

Key Details

Gender

All

Age Range

19 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2025-03

Completion Date

2030-12

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DRUG

Anticoagulation Monotherapy

Participants in the anticoagulation monotherapy group will receive apixaban 5 mg twice daily during the study period.

DRUG

Combination therapy

Participants in the combination therapy group will receive clopiogrel 75 mg daily and apixaban 5 mg twice daily during the study period.