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

NCT04475510 | Recruiting DMC

• 1 other identifier: HALTI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patent Foramen Ovale; Ischemic Stroke; Bleeding Ulcer

Keywords

Transcatheter Patent Foramen Ovale (PFO) closure; Ischemic Stroke; Bleeding; Young patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Number of new cerebral ischemic lesions

  24-month follow-up

• Volume of new cerebral ischemic lesions

  24-month follow-up

• Number of ischemic events

  24-month follow-up

• Number of ischemic events

  3-year follow-up

• Number of ischemic events

  4-year follow-up

Study Arms (1)

Antiplatelet treatment discontinuation

EXPERIMENTAL

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

Interventions

Antiplatelet treatment discontinuation 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.

Antiplatelet treatment discontinuation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Successful transcatheter PFO closure with any approved device
• Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure

You may not qualify if:

• \>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

Sponsors & Collaborators

• Josep Rodes-Cabau: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Josep Rodes-Cabau, MD

CONTACT

4186568711; josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

CONTACT

14186537270; melanie.cote@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: July 8, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2032
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CA (1)