NCT07496281Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2 (estimated)
- First submitted
- 15 Mar 2026
- Start date
- 1 Mar 2027
- Primary completion date
- 28 Feb 2032
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- NCT number
- NCT07496281
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2
- From 1 Mar 2027 to the primary completion date, 28 Feb 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ewha Womans University Mokdong Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.