Prospective Registry of Elderly ESUS With PFO (COACH_ESUS)

Asan Medical Center

Status: Enrolling

Conditions: Embolic Stroke of Undetermined Source

Treatments: Procedure: PFO closure

Study type: Observational

Funder types: Other

Identifiers

NCT05238610

COACH_ELDERLY_ESUS_NECA_2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 2 patient groups

Experimental: intervention group

Description:

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

Treatment:

Procedure: PFO closure

Active comparator: control group

Description:

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