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

RECRUITINGN/ASponsored by Josep Rodes-Cabau
Actively Recruiting
PhaseN/A
SponsorJosep Rodes-Cabau
Started2020-07-08
Est. completion2025-06-01
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04475510

Summary

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

Eligibility

Age: 18 Years – 60 YearsHealthy volunteers accepted
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

Conditions4

Bleeding UlcerHeart DiseaseIschemic StrokePatent Foramen Ovale

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