NCT06866665Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1400 (estimated)
- First submitted
- 23 Feb 2025
- Start date
- Mar 2025
- Primary completion date
- Dec 2030
- Lead sponsor
- Yonsei University
- NCT number
- NCT06866665
What you commit to
- Study type: Interventional
- Planned participants: 1400
- From Mar 2025 to the primary completion date, Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received PCI or CABG within 6 months.
- Patients who is not able to receive apixaban or clopidogrel due to previous adverse reaction.
- Patiens who are not able to discontinue a drug related to CYP3A4 inhibition.
Other illness
- Patients with a history of acute coronary syndrome within 12 months.
- Patients who have coagulopathy or have a history of recurrent bleeding.
- Intracranial or gastrointestinal bleeding within 3 months.
- Life expectancy \< 1 year due to malignancy.
Age
- \>85 years old.
Other
- Patients who require anticoagulation with warfarin due to a mechanical prosthetic valve, or ≥ moderate mitral stenosis.
- Patients with a comorbidity requiring anticoagulation other than AF.
- Gastrointestinal tumor requiring treatment.
- Patients who are pregnant or those who report potential pregnancy.
- Refuse or enable to understand the written informed consent.
Who the study is looking for
- ≥ 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
Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.