OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation (NCT07496281) | Clinical Trial Compass
Not Yet RecruitingPhase 4
OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation
South Korea2 participantsStarted 2027-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. 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.
2. 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with net clinical outcome events