Anticoagulation Monotherapy
DrugParticipants in the anticoagulation monotherapy group will receive apixaban 5 mg twice daily during the study period.
Other names: Apixaban monotherapy
NCT Number: NCT06866665
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.
Trial opening soon.
Get Notified19 year–85 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the anticoagulation monotherapy group will receive apixaban 5 mg twice daily during the study period.
Other names: Apixaban monotherapy
Participants in the combination therapy group will receive clopiogrel 75 mg daily and apixaban 5 mg twice daily during the study period.
Other names: Apixaban and clopidogrel combination therapy
Time frame: 12 months after the last enrollment
NACE is defined as a composite of all-cause death, MI, stroke, systemic embolism, and major or clinically relevant non-major (CRNM) bleeding as defined by International Society on Thrombosis and Hemostasis (ISTH) criteria.
Time frame: 12 months after the last enrollment
Composite bleeding event: a composite of ISTH major or CRNM bleeding
Time frame: 12 months after the last enrollment
Major adverse cardiac event (MACE): a composite of cardiovascular death, MI, or any coronary revascularization
Time frame: 12 months after the last enrollment
Key ischemic event: a composite of cardiovascular death, MI, ischemic stroke, or systemic embolism
Time frame: 12 months after the last enrollment
all-cause death
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
PCI (Percutaneous Coronary Intervention), CABG(Coronary Artery Bypass Graft)
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
Time frame: 12 months after the last enrollment
stroke
Time frame: 12 months after the last enrollment
systemic embolism
Time frame: 12 months after the last enrollment
ISTH major bleeding
Time frame: 12 months after the last enrollment
ISTH CRNM bleeding
Time frame: 12 months after the last enrollment
MI
Contact information is provided by the study sponsor or research team.
Yonsei University
Other
ADequate AntiPlatelet and Anticoagulation Therapy in Atrial Fibrillation Patients With Focus on Ischemic Risk Management A Randomized ADAPT AFFIRM Study
Acronym: ADAPT AFFIRM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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