Recruiting

Antithrombotic Treatment

Sponsor:

Josep Rodes-Cabau

Code:

NCT04475510

Conditions

Patent Foramen Ovale

Ischemic Stroke

Bleeding Ulcer

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Antiplatelet treatment discontinuation

Study Details

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

Study ID

NCT04475510

Start date

Jul 8, 2020

Status verified date

Mar, 2026

Completion date

Aug 1, 2032

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Presence of new stroke events [ Time Frame: 12 months ]
  • Presence of new ischemic lesions [ Time Frame: 24-month follow-up ]

Central Contacts and Locations

Central contacts

Josep Rodes-Cabau, MD

4186568711josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

14186537270melanie.cote@criucpq.ulaval.ca

Locations

IUCPQ

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Josep Rodes-Cabau, MD

4186568711josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

4186568711josep.rodes@criucpq.ulaval.ca

Principal Investigator:

Josep Rodes-Cabau, MD

More Information

Sponsor

Josep Rodes-Cabau

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Josep Rodes-Cabau on 2026-03-24.