Prospective Registry of Elderly ESUS With PFO

Study Overview
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Brief Summary
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Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

Detailed Description
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The COACH-ELDERLY ESUS study is a multicenter, prospective, registry-based, observational study in elderly ESUS patients with high-risk PFO treated with PFO-closure + standard antiplatelet treatment or standard antiplatelet treatment only in 20 centers in Korea. Patients will receive an insertable loop recorder (ILR) to monitor paroxysmal atrial fibrillation. In cases, which are unavailable for ILR, recurrent EKG or Holter monitoring will be done based on the clinician's decision. Based on the attending physicians' decision with a multi-disciplinary approach, patients will receive PFO-closure with standard antiplatelet treatment or standard antiplatelet treatment only.

Official Title
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Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale

Conditions
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Embolic Stroke of Undetermined Source

Intervention / Treatment
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* Procedure: PFO closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 60 years-old Patients diagnosed as ESUS within 180 days from onset PFO found from TTE or TEE, which attributed to the ischemic stroke Patients or their legal representative agreed to participate Exclusion Criteria: Patients with transient ischemic attack Patients with ischemic stroke at the vascular territory with significant stenosis Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease) Patients with active cancer Patients who need long term anticoagulation Patients who have side effect on antiplatelet treatment Patients with active internal bleeding Patients who refuse to participate

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>This group will receive PFO-closure and standard antiplatelet treatment PFO-closure will be performed after 3-6 months of observation and monitoring for paroxysmal atrial fibrillation Standard antiplatelet treatment will be prescribed - aspirin 100mg and clopidogrel 75mg, once daily, principally. However, the final decision of antiplatelet treatment will be made by the physician. If paroxysmal atrial fibrillation is detected, anticoagulation will be considered. Intervention : PFO closure Drug: aspirin 100mg/day Drug: clopidogrel 75mg/day | Procedure: PFO closure<br>* PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation<br>|
| Active comparator: control group<br>This group will receive standard antiplatelet treatment only Dual antiplatelet treatment with Aspirin 100mg and Clopidogrel 75mg, once daily, or single antiplatelet treatment with those agents can be considered. If paroxysmal atrial fibrillation is detected, anticoagulation will be considered. Drug: aspirin 100mg/day Drug: clopidogrel 75mg/day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemic stroke recurrence | Time to occurrence of ischemic stroke after registration | at least 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Time to major cardiovascular event after registration | at least 1 year | 
| Hemorrhagic stroke | Time to hemorrhagic stroke after registration | at least 1 year | 
| Vascular death | Time to vascular death after registration | at least 1 year | 
| Myocardial infarction | Time to myocardial infarction | at least 1 year | 
| Atrial fibrillation after registration | Time to atrial fibrillation after registration | at least 1 year | 
| Atrial fibrillation lasting more than 2 or 6 min after registration | Time to atrial fibrillation lasting more than 2 or 6 min after registration | at least 1 year | 
| Major bleeding | Time to major bleeding event after registration | at least 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insertable loop recorder, patent foramen ovale, patent foramen ovale closure, elderly