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

NCT07496281 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2027-03-01
Last updated
2026-03-27

Condition(s) studied

Atrial Fibrillation (AF)Coronary Artery DiseaseDrug-eluting Stent

Investigational drug(s) / intervention(s)

Oral anticoagulationSingle antiplatelet therapy

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

Single antiplatelet therapy: Single antiplatelet therapy such as aspirin or a P2Y12 inhibitor.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of participants with net clinical outcome events — From randomization up to 24 months
    Composite of ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding, assessed as time-to-first event.

Trial sites (1)

FacilityCityRegionStatus
Ewha Womans University Mokdong Hospital Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07496281 on ClinicalTrials.gov ↗ ← All trials in South Korea