Prospective Registry of Elderly ESUS With PFO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-17

Study Completion Date

2027-05-31

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

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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.

Conditions

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Embolic Stroke of Undetermined Source

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental: intervention group

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

PFO closure

Intervention Type PROCEDURE

PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation

Active comparator: control group

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

No interventions assigned to this group

Interventions

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PFO closure

PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation

Intervention Type PROCEDURE

Eligibility Criteria

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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

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No