NCT07496281

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Ewha Womans University Mokdong Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Atrial fibrillation (AF) and coronary artery disease frequently coexist, creating a complex clinical scenario in which patients require antithrombotic therapy for prevention of both thromboembolic and coronary ischemic events. Current guideline-directed management generally recommends long-term oral anticoagulation in patients with AF based on stroke risk stratification, while antiplatelet therapy remains central for prevention of stent-related ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Catheter ablation has become an established rhythm-control strategy for AF, and a substantial proportion of patients achieve durable maintenance of sinus rhythm after the procedure. Emerging evidence suggests that sustained sinus rhythm following successful ablation may reduce AF-related thromboembolic risk by decreasing atrial arrhythmia burden and atrial stasis. However, the optimal long-term antithrombotic strategy in patients who maintain stable sinus rhythm after ablation and have a prior history of DES implantation remains uncertain. The OPTIA-AF trial (Optimal Post-ablation Therapy for Ischemic and Arrhythmic Risk in Atrial Fibrillation) is designed to evaluate whether a rhythm-guided strategy of discontinuing oral anticoagulation with transition to single antiplatelet therapy is non-inferior to continued NOAC therapy in patients with durable sinus rhythm after AF ablation. This prospective, multicenter, open-label randomized controlled trial will enroll approximately 1,000 patients with nonvalvular AF who have maintained sinus rhythm for at least 12 months following catheter ablation and are at least 12 months removed from DES implantation. Eligible participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with transition to single antiplatelet therapy (SAPT). Structured rhythm surveillance including electrocardiography and ambulatory rhythm monitoring will be performed during follow-up. Participants will be followed for 24 months. The primary endpoint is a composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding. Secondary outcomes include AF recurrence, AF burden, arrhythmia-related hospitalization, repeat catheter ablation, and individual components of the primary composite endpoint.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2027-03-01
• Primary completion: 2032-02-28
• Completion: 2035-03-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: South Korea