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

NCT07496281 | Not Yet Recruiting Phase 4

• 1 other identifier: OPTIA-AF
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Atrial fibrillation ablation; Antithrombotic therapy; Oral anticoagulation; Non-vitamin K antagonist oral anticoagulant; Single antiplatelet therapy; Drug-eluting stent; Rhythm-guided strategy; Catheter ablation; Randomized controlled trial

Outcome Measures

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.

  From randomization up to 24 months

Secondary Outcomes (11)

• Number of participants with ischemic stroke

  From randomization up to 24 months

• Number of participants with systemic embolism

  From randomization up to 24 months

• Number of participants with myocardial infarction

  From randomization up to 24 months

• Number of participants with definite or probable stent thrombosis

  From randomization up to 24 months

• Number of participants with cardiovascular death

  From randomization up to 24 months

Other Outcomes (1)

• Number of participants with any adverse events

  From randomization up to 24 months

Study Arms (2)

Rhythm-guided antithrombotic strategy

EXPERIMENTAL

Discontinuation of oral anticoagulation with continuation of single antiplatelet therapy after atrial fibrillation ablation.

Drug: Single antiplatelet therapy

Continuous oral anticoagulation

ACTIVE COMPARATOR

Continuation of oral anticoagulation therapy after atrial fibrillation ablation in patients with prior drug-eluting stent implantation.

Drug: Oral anticoagulation

Interventions

Oral anticoagulation DRUG

Non-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation.

Continuous oral anticoagulation

Single antiplatelet therapy DRUG

Single antiplatelet therapy such as aspirin or a P2Y12 inhibitor.

Rhythm-guided antithrombotic strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, 07804, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Yeji Kim, MD, PhD

CONTACT

+82-10-8680-9542; lexie6169@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): February 28, 2032
• Study Completion (Estimated): March 1, 2035
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.
• Access Criteria: Access will be provided to qualified researchers for scientific purposes following approval of a research proposal.

Locations

KR (1)