OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation
NCT07496281 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2026-03-27
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.
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.
Sponsors & Collaborators
-
Ewha Womans University Mokdong Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-03-01
- Primary Completion
- 2032-02-28
- Completion
- 2035-03-01
Countries
- South Korea
Study Locations
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