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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Oral anticoagulation
DrugNon-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation.
Single antiplatelet therapy
DrugSingle antiplatelet therapy such as aspirin or a P2Y12 inhibitor.
Treatment groups
2 Participants
are divided into 2 treatment groupsGroup A: Rhythm-guided antithrombotic strategyExperimental treatment 1 intervention
Group B: Continuous oral anticoagulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with net clinical outcome events
Composite of ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding, assessed as time-to-first event.
Time frame
From randomization up to 24 monthsSecondary outcomes
1
Number of participants with ischemic stroke
Occurrence of ischemic stroke, defined according to standard clinical criteria.
Time frame
From randomization up to 24 months2
Number of participants with systemic embolism
Occurrence of systemic embolism confirmed by imaging or clinical diagnosis.
Time frame
From randomization up to 24 months3
Number of participants with myocardial infarction
Occurrence of myocardial infarction defined according to universal definition criteria.
Time frame
From randomization up to 24 months4
Number of participants with definite or probable stent thrombosis
Occurrence of definite or probable stent thrombosis according to ARC criteria.
Time frame
From randomization up to 24 monthsOther outcomes
1
Number of participants with any adverse events
Occurrence of adverse events including bleeding, drug-related adverse events, and serious adverse events.
Time frame
From randomization up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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