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

Not Applicable

Recruiting

• Conditions: Patent Foramen Ovale; Bleeding Ulcer; Ischemic Stroke
• Interventions: Other: Antiplatelet treatment discontinuation

• Registration Number: NCT04475510
• Lead Sponsor: Josep Rodes-Cabau

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2020-07-08
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2025-06-01
• Study Completion: 2032-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antiplatelet treatment discontinuation	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.

Primary Outcome Measures

Name	Time	Method
Presence of new ischemic lesions	24-month follow-up	Evaluated by MRI
Presence of new stroke events	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of new cerebral ischemic lesions	24-month follow-up	Evaluated by MRI
Rate of bleeding	10-year follow-up	Life-threatening, major or minor bleeding
Volume of new cerebral ischemic lesions	24-month follow-up	Evaluated by MRI
Number of ischemic events	10-year follow-up	Stroke, TIA

Trial Locations

Locations (1)

IUCPQ; 🇨🇦 Quebec, Canada