Patent Foramen OvaleHALTINCT04475510
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
A study testing Antiplatelet treatment discontinuation in people with Patent Foramen Ovale and Ischemic Stroke, run by Josep Rodes-Cabau at 1 site in Canada.
Trial summary
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer
- What is being tested?
- Antiplatelet treatment discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2020to 1 Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Successful transcatheter PFO closure with any approved device
- Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
Who cannot join
- ->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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
IUCPQ
Québec, Quebec, G1V 4G5
Josep Rodes-Cabau, MD, 4186568711, josep.rodes@criucpq.ulaval.ca
Melanie Cote, MSc, 4186568711 ext. Rodes-Cabau, josep.rodes@criucpq.ulaval.ca
About this study
Official title: Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
Read the detailed description
Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events.
Importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO closure.
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer
- Being tested
- Antiplatelet treatment discontinuation
- Keywords
- Transcatheter Patent Foramen Ovale (PFO) closure, Ischemic Stroke, Bleeding, Young patients
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet treatment discontinuationOther
All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet treatment discontinuation | Experimental | 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. Receives: Other: Antiplatelet treatment discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of new stroke events
1)Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax or other new neurological symptom(s) consistent with stroke.(2)Duration of a focal or global neurological deficit ≥ 24 hours OR < 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death.
Measured: 12 months
Presence of new ischemic lesions
Evaluated by MRI
Measured: 24-month follow-up
Secondary outcomes (20)
Number of new cerebral ischemic lesions
Evaluated by MRI
Measured: 24-month follow-up
Volume of new cerebral ischemic lesions
Evaluated by MRI
Measured: 24-month follow-up
Number of ischemic events
Stroke, TIA
Measured: 24-month follow-up
Number of ischemic events
Stroke, TIA
Measured: 3-year follow-up
Number of ischemic events
Stroke, TIA
Measured: 4-year follow-up
Number of ischemic events
Stroke, TIA
Measured: 5-year follow-up
Number of ischemic events
Stroke, TIA
Measured: 6-year follow-up
Number of ischemic events
Stroke, TIA
Measured: 7-year follow-up
Number of ischemic events
Stroke, TIA
Measured: 8-year follow-up
Number of ischemic events
Stroke, TIA
Measured: 9-year follow-up
Number of ischemic events
Stroke, TIA
Measured: 10-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 24-month follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 3-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 4-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 5-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 6-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 7-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 8-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 9-year follow-up
Rate of bleeding
Life-threatening, major or minor bleeding
Measured: 10-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start8 Jul 2020
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josep Rodes-Cabau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475510
- Sponsor's protocol ID
- HALTI
- Acronym
- HALTI
- Status last verified
- Nov 2026
- First submitted
- 14 Jul 2020
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
- ClinicalTrials.gov ID
- NCT04475510
- Acronym / sponsor ID
- HALTI / HALTI
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer
- Keywords
- Transcatheter Patent Foramen Ovale (PFO) closure, Ischemic Stroke, Bleeding, Young patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Josep Rodes-CabauUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2032 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
Detailed description
Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events.
Importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet treatment discontinuation | Experimental | Other: Antiplatelet treatment discontinuationAt 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Successful transcatheter PFO closure with any approved device
- Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
Key exclusion criteria (10 listed)
- ->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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiplatelet treatment discontinuationAll patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure. | Other | Antiplatelet treatment discontinuation |
Primary outcome
Presence of new stroke events
Time frame: 12 months
1)Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax or other new neurological symptom(s) consistent with stroke.(2)Duration of a focal or global neurological deficit ≥ 24 hours OR < 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death.
Presence of new ischemic lesions
Time frame: 24-month follow-up
Evaluated by MRI
20 secondary outcomes
Number of new cerebral ischemic lesions
Time frame: 24-month follow-up
Volume of new cerebral ischemic lesions
Time frame: 24-month follow-up
Number of ischemic events
Time frame: 24-month follow-up
Number of ischemic events
Time frame: 3-year follow-up
Number of ischemic events
Time frame: 4-year follow-up
Number of ischemic events
Time frame: 5-year follow-up
Number of ischemic events
Time frame: 6-year follow-up
Number of ischemic events
Time frame: 7-year follow-up
Number of ischemic events
Time frame: 8-year follow-up
Number of ischemic events
Time frame: 9-year follow-up
Number of ischemic events
Time frame: 10-year follow-up
Rate of bleeding
Time frame: 24-month follow-up
Rate of bleeding
Time frame: 3-year follow-up
Rate of bleeding
Time frame: 4-year follow-up
Rate of bleeding
Time frame: 5-year follow-up
Rate of bleeding
Time frame: 6-year follow-up
Rate of bleeding
Time frame: 7-year follow-up
Rate of bleeding
Time frame: 8-year follow-up
Rate of bleeding
Time frame: 9-year follow-up
Rate of bleeding
Time frame: 10-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiplatelet treatment discontinuation in people with Patent Foramen Ovale and Ischemic Stroke, run by Josep Rodes-Cabau at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josep Rodes-Cabau, MD (4186568711, josep.rodes@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of new stroke events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.