Stopping blood thinners after closing a heart defect in young stroke patients
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
NA · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · NCT04475510
This study is testing if young stroke patients can safely stop taking blood thinners a year after having a heart defect fixed.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval (other) |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT04475510 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are young patients aged 60 or younger who have had a cryptogenic stroke and successfully undergone PFO closure.
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.
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 performed: Preliminary data from similar studies suggest that discontinuing antiplatelet therapy may not increase the risk of ischemic events, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Québec, Quebec
- IUCPQ — Québec, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Josep Rodes-Cabau, MD
- Email: josep.rodes@criucpq.ulaval.ca
- Phone: 4186568711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer, Transcatheter Patent Foramen Ovale closure, Bleeding, Young patients