OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEwha Womans University Mokdong Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Oral anticoagulation
- Single antiplatelet therapy
Treatment groups
2 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov