Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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. 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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Sun U Kwon, MD. PhD
sukwon@amc.seoul.kr
82-2-3010-3960
Backup
Bum Joon Kim, MD PhD
bj.kim@amc.seoul.kr
82-2-3010-3981
Time Frame
Start Date: 2022-01-17
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 1200
Treatments
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
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
Related Therapeutic Areas
Sponsors
Collaborators: National Evidence-Based Healthcare Collaborating Agency
Leads: Asan Medical Center