NCT04475510 Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
| NCT ID | NCT04475510 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Josep Rodes-Cabau |
| Condition | Patent Foramen Ovale |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-07-08 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2020-07-08 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: -\>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
Frequently Asked Questions
Who can join the NCT04475510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Patent Foramen Ovale. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04475510 currently recruiting?
Yes, NCT04475510 is actively recruiting participants. Visit ClinicalTrials.gov or contact Josep Rodes-Cabau to inquire about joining.
Where is the NCT04475510 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT04475510 clinical trial?
NCT04475510 is sponsored by Josep Rodes-Cabau. The trial plans to enroll 100 participants.