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

Josep Rodes-Cabau100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Patent Foramen Ovale Ischemic Stroke Bleeding Ulcer

Interventions

Antiplatelet treatment discontinuationOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IUCPQ

Québec, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Presence of new ischemic lesions

Evaluated by MRI

Time frame: 24-month follow-up

Secondary Outcomes

Number of new cerebral ischemic lesions

Evaluated by MRI

Time frame: 24-month follow-up

Volume of new cerebral ischemic lesions

Evaluated by MRI

Time frame: 24-month follow-up

Number of ischemic events

Stroke, TIA

Time frame: 24-month follow-up

Number of ischemic events

Stroke, TIA

Time frame: 3-year follow-up

Number of ischemic events

Stroke, TIA

Time frame: 4-year follow-up

Number of ischemic events

Stroke, TIA

Time frame: 5-year follow-up

Central Contacts

Josep Rodes-Cabau, MD

CONTACT

4186568711 josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

CONTACT

14186537270 melanie.cote@criucpq.ulaval.ca

Data from ClinicalTrials.gov

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