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

Recruiting now · Not applicable

Conditions studied: Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer

In brief

To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.

Key facts

Study ID

NCT04475510

Run by

Josep Rodes-Cabau

People needed

100

Starts

2020-07-08

Expected to finish

2032-08-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Successful transcatheter PFO closure with any approved device
• Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure

You may not qualify if…

• >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

Where it is running

• IUCPQ — Québec, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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