Not Yet RecruitingNot Applicable

Antithrombotic Strategy for AF Patients With High Risk CAD

1,400 participantsStarted 2025-03

Plain-language 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.

Who can participate

Age range19 Years – 85 Years

SexALL

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Inclusion criteria

✓. ≥ 19 years old
✓. Presence of AF with CHA2DS2-VASc score ≥ 2
✓. Patients with stable CAD - a history of percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) before 6 months (chronic coronary syndrome) or 12 months (acute coronary syndrome); anatomically confirmed CAD on coronary angiography or computed tomography scan
✓. Presence of an excessive ischemic risk i. A history of myocardial infarction (MI) ii. Complex PCI iii. Untreated lesion with \>50% stenosis at major epicardial vessel after coronary revascularization iv. Untreated multivessel CAD (\>50% stenosis of \>1 major epicardial vessel or left main stem) v. Peripheral artery disease vi. Cerebrovascular disease

Exclusion criteria

✕. \>85 years old.
✕. Patients who received PCI or CABG within 6 months.
✕. Patients with a history of acute coronary syndrome within 12 months.
✕. Patients who require anticoagulation with warfarin due to a mechanical prosthetic valve, or ≥ moderate mitral stenosis.

What they're measuring

Net adverse clinical event (NACE)

Timeframe: 12 months after the last enrollment

Trial details

NCT IDNCT06866665

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12

Contact for this trial

jung sun Kim, MD,PhD

+82-2-2228-8457 KJS1218@yuhs.ac

View on ClinicalTrials.gov More Atrial Fibrillation trials