Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease
Recruiting · NCT07753200 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
ApixabanEdoxaban
What this trial is about
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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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)
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Pregnant or lactating women
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, South Korea