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

Sponsor
Ewha Womans University Mokdong Hospital
Study ID
NCT07496281
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral anticoagulation — DRUG
    Non-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation.
  • Single antiplatelet therapy — DRUG
    Single antiplatelet therapy such as aspirin or a P2Y12 inhibitor.

Study Details

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.

Key Dates

First listed
Mar 27, 2026
Start date
Mar 1, 2027
Status verified
Mar 2026
Primary completion
Feb 28, 2032
Completion
Mar 1, 2035

Study Design

Enrollment
2 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rhythm-guided antithrombotic strategy
    Discontinuation of oral anticoagulation with continuation of single antiplatelet therapy after atrial fibrillation ablation.
  • Active Comparator: Continuous oral anticoagulation
    Continuation of oral anticoagulation therapy after atrial fibrillation ablation in patients with prior drug-eluting stent implantation.

Primary Outcome Measure

Number of participants with net clinical outcome events [ Time Frame: From randomization up to 24 months ]

Central Contacts

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