Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
Non-vitamin K antagonist oral anticoagulants(NOACs) are standard care for thromboembolism prevention in patients with Aterial Fibrillation(AF). However, evidence comparing edoxaban and apixaban remains limited in AF patients with coexisting coronary artery disease(CAD). This study aims to evaluate whether edoxaban-based therapy is non-interior to apixaban-based therapy with respect to Net Adverse Clinical Events(NACE) in AF patients with concomitant CAD.
Eligibility criteria
Qualifiers
Patients must be at least 19 years of age
Patients with AF requiring oral anticoagulation therapy (CHA2DS2-VaSc 2 or more)
Documented coronary artery disease, defined as at least one of the following: history of percutaneous coronary intervention (PCI), history of coronary artery bypass grafting (CABG), major epicardial coronary artery stenosis ≥50% on coronary computed tomography angiography (CCTA) or invasive coronary angiography
Patients who can understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
Disqualifiers
Known hypersensitivity or contraindications to study medications (apixaban or edoxaban)
Severe renal impairment (creatinine clearance <15 mL/min) or dialysis
Active major bleeding
Indication requiring alternative anticoagulation (e.g., mechanical valve surgery or moderate / severe mitral stenosis)
Trial design
Treatments tested in this trial
- Edoxaban
- Apixaban
Treatment groups
3,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov