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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2032-08-01

Brief Summary

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

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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.

Conditions

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Patent Foramen Ovale Ischemic Stroke Bleeding Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antiplatelet treatment discontinuation

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.

Group Type EXPERIMENTAL

Antiplatelet treatment discontinuation

Intervention Type OTHER

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

Interventions

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Antiplatelet 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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes