Atrial Fibrillation (AF)Phase 4OPTIA-AFNCT07496281
OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation
A Phase 4 study testing Oral anticoagulation and Single antiplatelet therapy in people with Atrial Fibrillation (AF) and Coronary Artery Disease, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Coronary Artery Disease, Drug-eluting Stent
- What is being tested?
- Oral anticoagulation and Single antiplatelet therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2027to 1 Mar 2035
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Ewha Womans University Mokdong Hospital
Seoul, 07804
Yeji Kim, MD, PhD, +82-10-8680-9542, lexie6169@gmail.com
About this study
Official title: OPTIA-AF Trial: A Randomized Study of Rhythm-Guided Antithrombotic Strategy After Atrial Fibrillation Ablation in Patients With Prior Drug-Eluting Stent Implantation
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.
Read the detailed description
Atrial fibrillation (AF) and coronary artery disease frequently coexist, creating a complex clinical scenario in which patients require antithrombotic therapy for prevention of both thromboembolic and coronary ischemic events. Current guideline-directed management generally recommends long-term oral anticoagulation in patients with AF based on stroke risk stratification, while antiplatelet therapy remains central for prevention of stent-related ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.
Catheter ablation has become an established rhythm-control strategy for AF, and a substantial proportion of patients achieve durable maintenance of sinus rhythm after the procedure. Emerging evidence suggests that sustained sinus rhythm following successful ablation may reduce AF-related thromboembolic risk by decreasing atrial arrhythmia burden and atrial stasis. However, the optimal long-term antithrombotic strategy in patients who maintain stable sinus rhythm after ablation and have a prior history of DES implantation remains uncertain.
The OPTIA-AF trial (Optimal Post-ablation Therapy for Ischemic and Arrhythmic Risk in Atrial Fibrillation) is designed to evaluate whether a rhythm-guided strategy of discontinuing oral anticoagulation with transition to single antiplatelet therapy is non-inferior to continued NOAC therapy in patients with durable sinus rhythm after AF ablation.
This prospective, multicenter, open-label randomized controlled trial will enroll approximately 1,000 patients with nonvalvular AF who have maintained sinus rhythm for at least 12 months following catheter ablation and are at least 12 months removed from DES implantation. Eligible participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with transition to single antiplatelet therapy (SAPT). Structured rhythm surveillance including electrocardiography and ambulatory rhythm monitoring will be performed during follow-up.
Participants will be followed for 24 months. The primary endpoint is a composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding. Secondary outcomes include AF recurrence, AF burden, arrhythmia-related hospitalization, repeat catheter ablation, and individual components of the primary composite endpoint.
- Being tested
- Oral anticoagulation, Single antiplatelet therapy
- 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
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral anticoagulationDrug
Non-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation.
Single antiplatelet therapyDrug
Single antiplatelet therapy such as aspirin or a P2Y12 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Rhythm-guided antithrombotic strategy | Experimental | Discontinuation of oral anticoagulation with continuation of single antiplatelet therapy after atrial fibrillation ablation. Receives: 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. Receives: Drug: Oral anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization up to 24 months
Secondary outcomes (11)
Number of participants with ischemic stroke
Occurrence of ischemic stroke, defined according to standard clinical criteria.
Measured: From randomization up to 24 months
Number of participants with systemic embolism
Occurrence of systemic embolism confirmed by imaging or clinical diagnosis.
Measured: From randomization up to 24 months
Number of participants with myocardial infarction
Occurrence of myocardial infarction defined according to universal definition criteria.
Measured: From randomization up to 24 months
Number of participants with definite or probable stent thrombosis
Occurrence of definite or probable stent thrombosis according to ARC criteria.
Measured: From randomization up to 24 months
Number of participants with cardiovascular death
Death resulting from cardiovascular causes.
Measured: From randomization up to 24 months
Number of participants with major bleeding
Major bleeding defined according to ISTH criteria.
Measured: From randomization up to 24 months
Number of participants with clinically relevant non-major bleeding
Clinically relevant non-major bleeding defined according to ISTH criteria.
Measured: From randomization up to 24 months
Number of participants with atrial fibrillation recurrence
Any documented atrial fibrillation episode lasting more than 30 seconds.
Measured: From randomization up to 24 months
Atrial fibrillation burden (percentage of time in AF)
Percentage of time in atrial fibrillation measured by ambulatory monitoring or wearable monitoring.
Measured: From randomization up to 24 months
Number of participants with arrhythmia-related hospitalization
Hospitalization related to atrial arrhythmia.
Measured: From randomization up to 24 months
Number of participants undergoing repeat catheter ablation
Repeat catheter ablation for recurrent atrial arrhythmia.
Measured: From randomization up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2027 (estimated)
- Primary completion28 Feb 2032 (estimated)
- Study completion1 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496281
- Sponsor's protocol ID
- OPTIA-AF
- Acronym
- OPTIA-AF
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding author after publication of the primary results.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIA-AF Trial: A Randomized Study of Rhythm-Guided Antithrombotic Strategy After Atrial Fibrillation Ablation in Patients With Prior Drug-Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT07496281
- Acronym / sponsor ID
- OPTIA-AF / OPTIA-AF
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 28 Feb 2032 (estimated)
- Study completion
- 1 Mar 2035 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atrial fibrillation (AF) and coronary artery disease frequently coexist, creating a complex clinical scenario in which patients require antithrombotic therapy for prevention of both thromboembolic and coronary ischemic events. Current guideline-directed management generally recommends long-term oral anticoagulation in patients with AF based on stroke risk stratification, while antiplatelet therapy remains central for prevention of stent-related ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.
Catheter ablation has become an established rhythm-control strategy for AF, and a substantial proportion of patients achieve durable maintenance of sinus rhythm after the procedure. Emerging evidence suggests that sustained sinus rhythm following successful ablation may reduce AF-related thromboembolic risk by decreasing atrial arrhythmia burden and atrial stasis. However, the optimal long-term antithrombotic strategy in patients who maintain stable sinus rhythm after ablation and have a prior history of DES implantation remains uncertain.
The OPTIA-AF trial (Optimal Post-ablation Therapy for Ischemic and Arrhythmic Risk in Atrial Fibrillation) is designed to evaluate whether a rhythm-guided strategy of discontinuing oral anticoagulation with transition to single antiplatelet therapy is non-inferior to continued NOAC therapy in patients with durable sinus rhythm after AF ablation.
This prospective, multicenter, open-label randomized controlled trial will enroll approximately 1,000 patients with nonvalvular AF who have maintained sinus rhythm for at least 12 months following catheter ablation and are at least 12 months removed from DES implantation. Eligible participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with transition to single antiplatelet therapy (SAPT). Structured rhythm surveillance including electrocardiography and ambulatory rhythm monitoring will be performed during follow-up.
Participants will be followed for 24 months. The primary endpoint is a composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding. Secondary outcomes include AF recurrence, AF burden, arrhythmia-related hospitalization, repeat catheter ablation, and individual components of the primary composite endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm-guided antithrombotic strategy | Experimental | Drug: Single antiplatelet therapyDiscontinuation of oral anticoagulation with continuation of single antiplatelet therapy after atrial fibrillation ablation. |
| Continuous oral anticoagulation | Active comparator | Drug: Oral anticoagulationContinuation of oral anticoagulation therapy after atrial fibrillation ablation in patients with prior drug-eluting stent implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral anticoagulationNon-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation. | Drug | Continuous oral anticoagulation |
| Single antiplatelet therapySingle antiplatelet therapy such as aspirin or a P2Y12 inhibitor. | Drug | Rhythm-guided antithrombotic strategy |
Primary outcome
Number of participants with net clinical outcome events
Time frame: From randomization up to 24 months
Composite of ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding, assessed as time-to-first event.
11 secondary outcomes
Number of participants with ischemic stroke
Time frame: From randomization up to 24 months
Number of participants with systemic embolism
Time frame: From randomization up to 24 months
Number of participants with myocardial infarction
Time frame: From randomization up to 24 months
Number of participants with definite or probable stent thrombosis
Time frame: From randomization up to 24 months
Number of participants with cardiovascular death
Time frame: From randomization up to 24 months
Number of participants with major bleeding
Time frame: From randomization up to 24 months
Number of participants with clinically relevant non-major bleeding
Time frame: From randomization up to 24 months
Number of participants with atrial fibrillation recurrence
Time frame: From randomization up to 24 months
Atrial fibrillation burden (percentage of time in AF)
Time frame: From randomization up to 24 months
Number of participants with arrhythmia-related hospitalization
Time frame: From randomization up to 24 months
Number of participants undergoing repeat catheter ablation
Time frame: From randomization up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding author after publication of the primary results.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral anticoagulation and Single antiplatelet therapy in people with Atrial Fibrillation (AF) and Coronary Artery Disease, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeji Kim, MD, PhD (+82-10-8680-9542, lexie6169@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with net clinical outcome events (time frame: From randomization up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.