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NCT07496281

PHASE4

OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation

Sponsor: Ewha Womans University Mokdong Hospital

View on ClinicalTrials.gov

Summary

The OPTIA-AF trial is a prospective, multicenter randomized controlled trial designed to evaluate a rhythm-guided antithrombotic strategy in patients with atrial fibrillation (AF) who maintain durable sinus rhythm after catheter ablation and have a history of prior drug-eluting stent (DES) implantation. Current guidelines generally recommend long-term oral anticoagulation (OAC) in patients with AF, even after successful ablation, while antiplatelet therapy remains essential for prevention of coronary ischemic events following percutaneous coronary intervention. OPTIA-AF tests whether discontinuation of non-vitamin K antagonist oral anticoagulant (NOAC) therapy with transition to single antiplatelet therapy (SAPT) is non-inferior to continued NOAC therapy in patients who maintain sinus rhythm for at least 12 months after AF ablation. Participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with SAPT. The primary endpoint is a 24-month composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding.

Official title: OPTIA-AF Trial: A Randomized Study of Rhythm-Guided Antithrombotic Strategy After Atrial Fibrillation Ablation in Patients With Prior Drug-Eluting Stent Implantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-03-01

Completion Date

2035-03-01

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Atrial Fibrillation (AF)Coronary Artery Disease Drug-eluting Stent

Interventions

DRUG

Oral anticoagulation

Non-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation.

DRUG

Single antiplatelet therapy

Single antiplatelet therapy such as aspirin or a P2Y12 inhibitor.

1. Inclusion Criteria * Participants must meet all of the following criteria: * Age ≥18 years. * Documented history of atrial fibrillation (paroxysmal or persistent). * Successful catheter ablation for atrial fibrillation performed within the previous 3-6 months. * Maintenance of sinus rhythm after ablation, confirmed by follow-up electrocardiography or rhythm monitoring. * History of percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. * Completion of the recommended duration of dual antiplatelet therapy (DAPT) following PCI. * Currently receiving oral anticoagulation therapy with a non-vitamin K antagonist oral anticoagulant (NOAC). * Clinically stable and considered eligible for long-term antithrombotic therapy adjustment by the treating physician. * Ability to understand the study procedures and provide written informed consent. 2. Exclusion Criteria * Participants will be excluded if any of the following criteria are present: * Recurrent atrial fibrillation documented after the index ablation procedure requiring repeat ablation or antiarrhythmic escalation. * Presence of mechanical heart valve or moderate-to-severe mitral stenosis. * Indication for long-term anticoagulation independent of atrial fibrillation (e.g., venous thromboembolism, mechanical valve). * Recent acute coronary syndrome or PCI within the past 3 months. * Planned coronary revascularization or cardiac surgery. * History of intracranial hemorrhage or other major bleeding that contraindicates antithrombotic therapy. * Severe renal dysfunction (e.g., estimated glomerular filtration rate \<30 mL/min/1.73 m²). * Severe hepatic dysfunction associated with coagulopathy. * Known hypersensitivity or contraindication to aspirin or NOAC therapy. * Pregnancy or breastfeeding. * Life expectancy less than 1 year due to non-cardiovascular comorbidities. * Participation in another interventional clinical trial that may interfere with the study outcomes.

Locations (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea