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Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID04475510

Safety of Stopping Antiplatelet Treatment 12 Months After Patent Foramen Ovale Closure in Adults Aged 18 to 60 With Cryptogenic Stroke

Led by Josep Rodes-Cabau · Updated on 2026-03-24

100

Participants Needed

1

Research Sites

321 weeks

Total Duration

AI-Summary

What this Trial Is About

This trial investigates the safety of stopping antithrombotic treatment 12 months after successful transcatheter closure of a patent foramen ovale PFO in young patients who have had a cryptogenic stroke or transient ischemic attack TIA. The study focuses on patients aged 18 to 60 years without other major risk factors, aiming to find out if shorter antiplatelet therapy after PFO closure reduces bleeding risks without increasing stroke or ischemic events. Participants will all have undergone successful PFO closure and will follow a plan to discontinue antiplatelet treatment 12 months after the procedure. Clinical evaluations and brain MRI scans are performed at 12 months before stopping treatment and again at 24 months post-PFO closure to monitor for new ischemic lesions or stroke events. During the study, participants will be closely monitored through clinical assessments and MRI imaging to detect any new strokes or ischemic brain lesions. Researchers will track the number and volume of new cerebral ischemic lesions and ischemic events over follow-ups extending up to 10 years, as well as bleeding rates. The total participation duration includes evaluations at 12 and 24 months, with continued monitoring of outcomes for several years.

CONDITIONS

Brief Title

Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke

Research Team

J

Josep Rodes-Cabau, MD

M

Melanie Cote, MSc

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