RecruitingNot ApplicableNCT04475510

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

Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial

Sponsor

Josep Rodes-Cabau

Enrollment

100 participants

Start Date

Jul 8, 2020

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke Bleeding Ulcer Patent foramen ovale

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

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 Criteria10

>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

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Interventions

OTHERAntiplatelet treatment discontinuation

All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.