Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Youn
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
| Condition(s) | Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure. |
| Who can participate | 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 MR |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Josep Rodes-Cabau |
| Locations | Québec, Quebec, Canada |
| Start date | 2020-07-08 |
| NCT ID | NCT04475510 |
| Official listing | https://clinicaltrials.gov/study/NCT04475510 |