Atrial Fibrillation (AF), Coronary Arterial Disease (CAD)
Conditions
Brief summary
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.
Detailed description
Non-vitamin K antagonist oral anticoagulants (NOACs) have become the standard of care for the prevention of thromboembolic events in patients with AF. In patients with AF and concomitant CAD, the choice of oral anticoagulant is particularly important because clinicians must balance the risks of thromboembolism, coronary ischemic events, as well as bleeding. Among available NOACs, apixaban and edoxaban share a common mechanism of factor Xa inhibition but differ substantially in dosing regimen, pharmacokinetic profile, and degree of renal elimination. In the recent COBRRA trial, apixaban was associated with significantly lower clinically relevant bleeding compared with rivaroxaban in patients with acute venous thromboembolism, without compromising efficacy against recurrent thromboembolism. Although these data support apixaban as an important benchmark NOAC, direct randomized comparisons between edoxaban and apixaban are lacking, particularly in patients with AF and coexisting CAD. Once-daily dosing and lower renal elimination fraction of edoxaban may offer practical advantages, particularly in elderly patients or those with impaired renal function, by potentially improving adherence and simplifying dose adjustment. Whether these pharmacological differences translate into meaningful differences in overall clinical outcomes remains uncertain. Given that anticoagulation strategies inherently require balancing thromboembolic protection against bleeding risk, evaluation using a net clinical outcome is clinically most relevant. Therefore, this randomized controlled trial is designed to determine whether edoxaban-based therapy is non-inferior to apixaban with respect to NACE, a composite of death, thromboembolic, and major bleeding outcomes in patients with AF and concomitant CAD.
Interventions
DRUGEdoxaban
Edoxaban 60mg will be administered once daily orally according to the study protocol.
DRUGApixaban
Apixaban 5mg will be administered twice a day orally according to the study protocol.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical Events (NACE) | 5 years | A composite of death from any causes, Myocardial Infarction, Stroke, systemic embolic events or International Society on Thrombosis and Hemostasis major bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACEE) | 5 years | a composite of death from any causes, Myocardial Infarction, or Stroke |
Countries
South Korea
Contacts
CONTACTJoo-Yong Hahn, MD, PhD
CONTACTKi-Hong Choi, MD, PhD
PRINCIPAL_INVESTIGATORJoo-yong Hahn, MD, PhD
Samsung Medical Center
Outcome results
None listed