Prospective Registry of Elderly ESUS With PFO

Recruiting

• Conditions: Embolic Stroke of Undetermined Source
• Interventions: Procedure: PFO closure

• Registration Number: NCT05238610
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-17
• Status Verified: 2022-02
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-14
• Last Update Posted: 2022-02-14
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Patients older than 60 years-old
2. Patients diagnosed as ESUS within 180 days from onset
3. PFO found from TTE or TEE, which attributed to the ischemic stroke
4. Patients or their legal representative agreed to participate

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Exclusion Criteria

1. Patients with transient ischemic attack
2. Patients with ischemic stroke at the vascular territory with significant stenosis
3. Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography
4. Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)
5. Patients with active cancer
6. Patients who need long term anticoagulation
7. Patients who have side effect on antiplatelet treatment
8. Patients with active internal bleeding
9. Patients who refuse to participate

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: intervention group	PFO closure	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

Primary Outcome Measures

Name	Time	Method
ischemic stroke recurrence	at least 1 year	Time to occurrence of ischemic stroke after registration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of