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

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

Detailed Description
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Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events. Importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO closure.

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

Conditions
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Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer

Intervention / Treatment
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* Other: Antiplatelet treatment discontinuation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: At 12 months post-PFO closure, patients will discontinue the antiplatelet treatment. All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antiplatelet treatment discontinuation<br>At 12 months post-PFO closure, patients will discontinue the antiplatelet treatment. All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure. | Other: Antiplatelet treatment discontinuation<br>* All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of new stroke events | 1)Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax or other new neurological symptom(s) consistent with stroke.(2)Duration of a focal or global neurological deficit ≥ 24 hours OR < 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death. | 12 months | 
| Presence of new ischemic lesions | Evaluated by MRI | 24-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new cerebral ischemic lesions | Evaluated by MRI | 24-month follow-up | 
| Volume of new cerebral ischemic lesions | Evaluated by MRI | 24-month follow-up | 
| Number of ischemic events | Stroke, TIA | 24-month follow-up | 
| Number of ischemic events | Stroke, TIA | 3-year follow-up | 
| Number of ischemic events | Stroke, TIA | 4-year follow-up | 
| Number of ischemic events | Stroke, TIA | 5-year follow-up | 
| Number of ischemic events | Stroke, TIA | 6-year follow-up | 
| Number of ischemic events | Stroke, TIA | 7-year follow-up | 
| Number of ischemic events | Stroke, TIA | 8-year follow-up | 
| Number of ischemic events | Stroke, TIA | 9-year follow-up | 
| Number of ischemic events | Stroke, TIA | 10-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 24-month follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 3-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 4-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 5-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 6-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 7-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 8-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 9-year follow-up | 
| Rate of bleeding | Life-threatening, major or minor bleeding | 10-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Patent Foramen Ovale (PFO) closure, Ischemic Stroke, Bleeding, Young patients