NCT07753200 Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease
| NCT ID | NCT07753200 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Samsung Medical Center |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2026-07-20 |
| Primary Completion | 2031-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,000 participants in total. It began in 2026-07-20 with a primary completion date of 2031-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Joo-yong Hahn, MD, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT07753200 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07753200 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07753200 currently recruiting?
Yes, NCT07753200 is actively recruiting participants. Contact the research team at Jooyong.hahn@gmail.com for enrollment information.
Where is the NCT07753200 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07753200 clinical trial?
NCT07753200 is sponsored by Samsung Medical Center. The principal investigator is Joo-yong Hahn, MD, PhD at Samsung Medical Center. The trial plans to enroll 3,000 participants.
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