An observational study in Embolic Stroke of Undetermined Source, sponsored by Asan Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-02-14.
Sponsored by Asan Medical Center · Observational
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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
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.
136 studies on the registry are indexed under Foramen Ovale, Patent; 47 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 254 across 59 observational studies indexed under Foramen Ovale, Patent.
Browse Foramen Ovale, Patent studies →Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Elderly ESUS patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation
ischemic stroke recurrence
Time to occurrence of ischemic stroke after registration
Time frame: at least 1 year
MACE
Time to major cardiovascular event after registration
Time frame: at least 1 year
Hemorrhagic stroke
Time to hemorrhagic stroke after registration
Time frame: at least 1 year
Vascular death
Time to vascular death after registration
Time frame: at least 1 year
Myocardial infarction
Time to myocardial infarction
Time frame: at least 1 year
Atrial fibrillation after registration
Time to atrial fibrillation after registration
Time frame: 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
Time frame: at least 1 year
Major bleeding
Time to major bleeding event after registration
Time frame: at least 1 year
Plan to share: Undecided
Started Jan 2022 (actual). Primary completion is estimated for May 2026, 52 months after the start.
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