Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease

ConditionsAtrial Fibrillation (AF)Coronary Arterial Disease (CAD)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Edoxaban
Drug
Edoxaban 60mg will be administered once daily orally according to the study protocol.
Apixaban
Drug
Apixaban 5mg will be administered twice a day orally according to the study protocol.

Treatment groups

3,000 Participants

are divided into 2 treatment groups

Group A: Edoxaban-based treatment groupExperimental treatment 1 intervention

Group B: Apixaban-based treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Net Adverse Clinical Events (NACE)

A composite of death from any causes, Myocardial Infarction, Stroke, systemic embolic events or International Society on Thrombosis and Hemostasis major bleeding

Time frame

5 years

Secondary outcomes

Major Adverse Cardiovascular and Cerebrovascular Events (MACEE)

a composite of death from any causes, Myocardial Infarction, or Stroke

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov

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