Actively Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
Led by Josep Rodes-Cabau · Updated on 2026-03-24
100
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the safety of stopping antithrombotic treatment 12 months after successful transcatheter closure of a patent foramen ovale (PFO) in young patients who have had a cryptogenic stroke or transient ischemic attack (TIA). The study focuses on patients aged 18 to 60 years without other major risk factors, aiming to find out if shorter antiplatelet therapy after PFO closure reduces bleeding risks without increasing stroke or ischemic events. Participants will all have undergone successful PFO closure and will follow a plan to discontinue antiplatelet treatment 12 months after the procedure. Clinical evaluations and brain MRI scans are performed at 12 months (before stopping treatment) and again at 24 months post-PFO closure to monitor for new ischemic lesions or stroke events. During the study, participants will be closely monitored through clinical assessments and MRI imaging to detect any new strokes or ischemic brain lesions. Researchers will track the number and volume of new cerebral ischemic lesions and ischemic events over follow-ups extending up to 10 years, as well as bleeding rates. The total participation duration includes evaluations at 12 and 24 months, with continued monitoring of outcomes for several years.
CONDITIONS
Brief Title
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Successful transcatheter PFO closure with any approved device
- Patients 60 years old or younger diagnosed with a cryptogenic stroke or TIA who have undergone successful transcatheter PFO closure
You will not qualify if you...
- Older than 60 years
- RoPE score less than 6
- Residual shunt moderate or greater following PFO closure
- Atrial fibrillation after PFO closure
- Presence of two or more 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive antiplatelet treatment following PFO closure for up to 12 months.
1 clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation)
Duration - 12 months
Participants discontinue antiplatelet treatment at 12 months and are monitored for safety and stroke recurrence.
1 clinical evaluation and cerebral MRI at 24 months post-PFO closure
Trial Site Locations
Total: 1 location
1
IUCPQ
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
Research Team
J
Josep Rodes-Cabau, MD
M
Melanie Cote, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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