NCT06866665

Antithrombotic Strategy for AF Patients With High Risk CAD

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigators will recruit 1400 patients with atrial fibrillation (AF) and coronary artery disease (CAD) with high ischemic risk. High ischemic risk is defined as acute myocardial infarction, complex percutaneous coronary intervention (PCI), untreated significant coronary stenosis, or polyvascular disease. Paticipants will be randomly assigned to either anticoagulation monotherapy group or combination therapy group. Participants assigned to the anticoagulation monotherapy group wil receive apixaban 5 mg twice daily (or reduced dose as judged by investigators) and those assigned to the combination therapy group will receive additional clopidogrel 75 mg daily on top of apixaban. Net adverse clinical events comprising all-cause death, myocardial infarction, stroke, systemic embolism, or ISTH major or clinically relevant non-major bleeding events will be evaluated at 12 months after randomization. Included participant will be followed up until the last participant will be followed up for at lease 12 months.

Conditions

• Atrial Fibrillation
• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-03-10
• Last updated: 2025-03-14