Stopping blood thinners after closing a heart defect in young stroke patients
Official title: Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
Run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · NCT04475510 · Data updated 2026-11-12
This study is testing if young stroke patients can safely stop taking blood thinners a year after having a heart defect fixed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Status | Recruiting |
| Started | July 8, 2020 |
| Main results expected | June 1, 2027 |
| Study ends | August 1, 2032 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT04475510 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are young patients aged 60 or younger who have had a cryptogenic stroke and successfully undergone PFO closure.
✕Probably not a fit
Patients over 60 years old or those with significant cardiovascular risk factors or recurrent cerebrovascular events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the safety of discontinuing antithrombotic treatment one year after successful closure of a patent foramen ovale (PFO) in young patients who have experienced a cryptogenic stroke. The research focuses on the potential for reduced bleeding risks associated with long-term antiplatelet therapy, which may outweigh the risk of ischemic events. By analyzing outcomes in patients who have undergone transcatheter PFO closure, the study seeks to determine if shorter-term antiplatelet treatment is a viable option for this population. The findings could lead to improved management strategies for young stroke patients post-PFO closure.
Why it matters
Potential benefit: If successful, this study could lead to safer treatment protocols that minimize bleeding risks for young patients after PFO closure.
How similar studies have gone: Preliminary data from similar studies suggest that discontinuing antiplatelet therapy may not increase the risk of ischemic events, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Iucpq
Québec, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Josep Rodes-Cabau, MD
- Email: josep.rodes@criucpq.ulaval.ca
- Phone: 4186568711
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.