Embolic Stroke of Undetermined SourceCOACH_ESUSNCT05238610
Prospective Registry of Elderly ESUS With PFO
An observational study of Embolic Stroke of Undetermined Source, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- What is being tested?
- PFO closure
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2022to 31 May 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly ESUS patients
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients who have side effect on antiplatelet treatment
- Patients with active internal bleeding
- Patients who refuse to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05055
Sun U Kwon, MD PhD, 02-3010-3960, sukwon@amc.seoul.kr
About this study
Official title: Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale
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
Read the 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.
- Conditions
- Embolic Stroke of Undetermined Source
- Being tested
- PFO closure
- Keywords
- insertable loop recorder, patent foramen ovale, patent foramen ovale closure, elderly
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO closureProcedure or surgery
PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: PFO closure | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic stroke recurrence
Time to occurrence of ischemic stroke after registration
Measured: at least 1 year
Secondary outcomes (7)
MACE
Time to major cardiovascular event after registration
Measured: at least 1 year
Hemorrhagic stroke
Time to hemorrhagic stroke after registration
Measured: at least 1 year
Vascular death
Time to vascular death after registration
Measured: at least 1 year
Myocardial infarction
Time to myocardial infarction
Measured: at least 1 year
Atrial fibrillation after registration
Time to atrial fibrillation after registration
Measured: 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
Measured: at least 1 year
Major bleeding
Time to major bleeding event after registration
Measured: at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start17 Jan 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Responsible party
- Principal investigator, Sun U. Kwon, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238610
- Sponsor's protocol ID
- COACH_ELDERLY_ESUS_NECA_2021
- Acronym
- COACH_ESUS
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kwon H, Lee PH, Song JK, Kwon SU, Kang DW, Kim JS. Patent Foramen Ovale Closure in Old Stroke Patients: A Subgroup Analysis of the DEFENSE-PFO Trial. J Stroke. 2021 May;23(2):289-292. doi: 10.5853/jos.2021.00647. Epub 2021 May 31. No abstract available.
PubMed 34102766Park S, Oh JK, Song JK, Kwon B, Kim BJ, Kim JS, Kang DW, Chang JY, Lee JS, Kwon SU. Transcranial Doppler as a Screening Tool for High-Risk Patent Foramen Ovale in Cryptogenic Stroke. J Neuroimaging. 2021 Jan;31(1):165-170. doi: 10.1111/jon.12783. Epub 2020 Sep 8.
PubMed 32896963Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.
PubMed 29544871Kim BJ, Kim NY, Kang DW, Kim JS, Kwon SU. Provoked right-to-left shunt in patent foramen ovale associates with ischemic stroke in posterior circulation. Stroke. 2014 Dec;45(12):3707-10. doi: 10.1161/STROKEAHA.114.007453. Epub 2014 Oct 30.
PubMed 25358696Kim BJ, Sohn H, Sun BJ, Song JK, Kang DW, Kim JS, Kwon SU. Imaging characteristics of ischemic strokes related to patent foramen ovale. Stroke. 2013 Dec;44(12):3350-6. doi: 10.1161/STROKEAHA.113.002459. Epub 2013 Sep 26.
PubMed 24072002Jung JM, Lee JY, Kim HJ, Do Y, Kwon SU, Kim JS, Song JK, Kang DW. Patent foramen ovale and infarct volume in cryptogenic stroke. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1399-404. doi: 10.1016/j.jstrokecerebrovasdis.2013.04.034. Epub 2013 Jun 5.
PubMed 23747019Lee JY, Song JK, Song JM, Kang DH, Yun SC, Kang DW, Kwon SU, Kim JS. Association between anatomic features of atrial septal abnormalities obtained by omni-plane transesophageal echocardiography and stroke recurrence in cryptogenic stroke patients with patent foramen ovale. Am J Cardiol. 2010 Jul 1;106(1):129-34. doi: 10.1016/j.amjcard.2010.02.025. Epub 2010 May 13.
PubMed 20609660
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale
- ClinicalTrials.gov ID
- NCT05238610
- Acronym / sponsor ID
- COACH_ESUS / COACH_ELDERLY_ESUS_NECA_2021
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- insertable loop recorder, patent foramen ovale, patent foramen ovale closure, elderly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: intervention group | – | Procedure: PFO closureThis 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 |
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly ESUS patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFO closurePFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation | Procedure or surgery | Experimental: intervention group |
Primary outcome
ischemic stroke recurrence
Time frame: at least 1 year
Time to occurrence of ischemic stroke after registration
7 secondary outcomes
MACE
Time frame: at least 1 year
Hemorrhagic stroke
Time frame: at least 1 year
Vascular death
Time frame: at least 1 year
Myocardial infarction
Time frame: at least 1 year
Atrial fibrillation after registration
Time frame: at least 1 year
Atrial fibrillation lasting more than 2 or 6 min after registration
Time frame: at least 1 year
Major bleeding
Time frame: at least 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 34102766Kwon H, Lee PH, Song JK, Kwon SU, Kang DW, Kim JS. Patent Foramen Ovale Closure in Old Stroke Patients: A Subgroup Analysis of the DEFENSE-PFO Trial. J Stroke. 2021 May;23(2):289-292. doi: 10.5853/jos.2021.00647. Epub 2021 May 31. No abstract available.
- Background: PubMed 32896963Park S, Oh JK, Song JK, Kwon B, Kim BJ, Kim JS, Kang DW, Chang JY, Lee JS, Kwon SU. Transcranial Doppler as a Screening Tool for High-Risk Patent Foramen Ovale in Cryptogenic Stroke. J Neuroimaging. 2021 Jan;31(1):165-170. doi: 10.1111/jon.12783. Epub 2020 Sep 8.
- Background: PubMed 29544871Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.
- Background: PubMed 25358696Kim BJ, Kim NY, Kang DW, Kim JS, Kwon SU. Provoked right-to-left shunt in patent foramen ovale associates with ischemic stroke in posterior circulation. Stroke. 2014 Dec;45(12):3707-10. doi: 10.1161/STROKEAHA.114.007453. Epub 2014 Oct 30.
- Background: PubMed 24072002Kim BJ, Sohn H, Sun BJ, Song JK, Kang DW, Kim JS, Kwon SU. Imaging characteristics of ischemic strokes related to patent foramen ovale. Stroke. 2013 Dec;44(12):3350-6. doi: 10.1161/STROKEAHA.113.002459. Epub 2013 Sep 26.
- Background: PubMed 23747019Jung JM, Lee JY, Kim HJ, Do Y, Kwon SU, Kim JS, Song JK, Kang DW. Patent foramen ovale and infarct volume in cryptogenic stroke. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1399-404. doi: 10.1016/j.jstrokecerebrovasdis.2013.04.034. Epub 2013 Jun 5.
- Background: PubMed 20609660Lee JY, Song JK, Song JM, Kang DH, Yun SC, Kang DW, Kwon SU, Kim JS. Association between anatomic features of atrial septal abnormalities obtained by omni-plane transesophageal echocardiography and stroke recurrence in cryptogenic stroke patients with patent foramen ovale. Am J Cardiol. 2010 Jul 1;106(1):129-34. doi: 10.1016/j.amjcard.2010.02.025. Epub 2010 May 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embolic Stroke of Undetermined Source, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun U Kwon, MD. PhD (82-2-3010-3960, sukwon@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic stroke recurrence (time frame: at least 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238610, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022; AzTrials last refreshed its copy on 26 Oct 2026.