Status:
RECRUITING
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Lead Sponsor:
Josep Rodes-Cabau
Conditions:
Patent Foramen Ovale
Ischemic Stroke
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
Detailed Description
Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventu...
Eligibility Criteria
Inclusion
- Successful transcatheter PFO closure with any approved device
- Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
Exclusion
- \>60 year-old
- RoPE score \<6
- Residual shunt ≥moderate following PFO closure
- Atrial fibrillation following PFO closure
- Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
- Diabetes mellitus
- Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)
- Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure
- Failure to provide signed informed consent
- Absolute contraindications for an MRI study
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2032
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04475510
Start Date
July 8 2020
End Date
August 1 2032
Last Update
July 11 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IUCPQ
Québec, Quebec, Canada, G1V 4G5