Net Clinical Benefit of Edoxaban versus Apixaban in Patients with Atrial Fibrillation and Coronary Artery Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0012323

Enrollment

3000

Registered

2026-07-23

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A total of 3,000 patients (1,500 in the edoxaban-based treatment group and 1,500 in the apixaban-based treatment group) will be recruited from participating multicenter sites in Korea. The stud

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: i) Patients must be at least 19 years of age ii) Patients with AF requiring oral anticoagulation therapy (CHA2DS2-VASc 2 or more) iii) 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 iv) Patients who can understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: i) Known hypersensitivity or contraindications to study medications (apixaban or edoxaban) ii) Severe renal impairment (creatinine clearance <15 mL/min) or dialysis iii) Active major bleeding iv) Indication requiring alternative anticoagulation (e.g., mechanical valve surgery or moderate / severe mitral stenosis) v) 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) vi) Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Major cardiovascular events (cardiovascular death, myocardial infarction, stroke, and unplanned revascularization)	—

Secondary

Measure	Time frame
death from any causes;death from cardiovascular causes;Myocardial Infarction;Stroke;systemic embolic events;International Society on Thrombosis and Haemostasis major bleeding;clinically relevant non-major bleeding by International Society on Thrombosis and Haemostasis criteria;International Society on Thrombosis and Haemostasis major bleeding or clinically relevant non-major bleeding;major adverse cardiac and cerebrovascular events (a composite of death from any causes, Myocardial Infarction, or ischemic stroke);a composite of death from any cause, Myocardial Infarction, ischemic stroke, or systemic embolic events;a composite of death from cardiovascular causes, Myocardial Infarction, ischemic stroke, or systemic embolic events;permanent discontinuation of study drug due to any adverse event	—

Measure

Time frame

death from any causes;death from cardiovascular causes;Myocardial Infarction;Stroke;systemic embolic events;International Society on Thrombosis and Haemostasis major bleeding;clinically relevant non-major bleeding by International Society on Thrombosis and Haemostasis criteria;International Society on Thrombosis and Haemostasis major bleeding or clinically relevant non-major bleeding;major adverse cardiac and cerebrovascular events (a composite of death from any causes, Myocardial Infarction, or ischemic stroke);a composite of death from any cause, Myocardial Infarction, ischemic stroke, or systemic embolic events;a composite of death from cardiovascular causes, Myocardial Infarction, ischemic stroke, or systemic embolic events;permanent discontinuation of study drug due to any adverse event

—

Countries

Korea, Republic of

Contacts

Public ContactJoo-Yong Hahn

Samsung Medical Center

jyhahn@skku.edu+82-2-3410-6653

Outcome results