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| Name | Class |
|---|---|
| National Evidence-Based Healthcare Collaborating Agency | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFO closure | Procedure | PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| ischemic stroke recurrence | Time to occurrence of ischemic stroke after registration | at least 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Time to major cardiovascular event after registration | at least 1 year |
| Hemorrhagic stroke | Time to hemorrhagic stroke after registration |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly ESUS patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun U Kwon, MD. PhD | Contact | 82-2-3010-3960 | sukwon@amc.seoul.kr | |
| Bum Joon Kim, MD PhD | Contact | 82-2-3010-3981 | bj.kim@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05055 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34102766 | Background | 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. | |
| 32896963 | Background | Park 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. |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| at least 1 year |
| Vascular death | Time to vascular death after registration | at least 1 year |
| Myocardial infarction | Time to myocardial infarction | at least 1 year |
| Atrial fibrillation after registration | Time to atrial fibrillation after registration | 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 | at least 1 year |
| Major bleeding | Time to major bleeding event after registration | at least 1 year |
| 29544871 | Background | Lee 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. |
| 25358696 | Background | Kim 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. |
| 24072002 | Background | Kim 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. |
| 23747019 | Background | Jung 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. |
| 20609660 | Background | Lee 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. |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |