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

Launched by JOSEP RODES-CABAU · Jul 14, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether it is safe for young patients to stop taking blood-thinning medications (antithrombotics) one year after having a successful procedure to close a small hole in the heart called a patent foramen ovale (PFO). This condition can sometimes be linked to unexplained strokes, known as cryptogenic strokes. The trial is currently looking for participants who are 60 years old or younger and have experienced a cryptogenic stroke or transient ischemic attack (TIA) but have successfully undergone the PFO closure procedure.

If eligible, participants will have the opportunity to be part of a study that aims to improve understanding of the risks and benefits of stopping these medications after PFO closure. Throughout the trial, participants will be closely monitored to ensure their safety. It’s important to note that individuals over 60 years old or those with certain health conditions (like diabetes or a history of multiple strokes) may not qualify for this study. If you or someone you know fits the criteria and is interested, participating could contribute valuable information to medical science about stroke prevention in younger patients.

Gender

ALL

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