HALTI trial: could stopping blood thinners after heart repair be safer?
NCT ID NCT04475510
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether people aged 60 or younger who had a stroke caused by a hole in the heart (PFO) can safely stop taking blood thinners one year after the hole is closed. The goal is to see if stopping these drugs reduces the risk of bleeding without increasing the chance of another stroke. About 100 participants will be followed with brain scans to check for new strokes or silent brain injuries.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Aug 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IUCPQ
RECRUITINGQuébec, Quebec, G1V 4G5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to catch a hidden heart rhythm after stroke
- Blood test may reveal who recovers after a stroke
- Can a smart bracelet and app stop a second stroke?
- Pharmacist and coach team takes aim at blood pressure after stroke