Clinical trial NCT04475510: Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Official title: Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patent Foramen Ovale
Ischemic Stroke
Bleeding Ulcer
Keywords: Transcatheter Patent Foramen Ovale (PFO) closure
Ischemic Stroke
Bleeding
Young patients
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Presence of new stroke events
timeFrame: 12 months
measure: Presence of new ischemic lesions
timeFrame: 24-month follow-up
Secondary outcomes:
measure: Number of new cerebral ischemic lesions
timeFrame: 24-month follow-up
measure: Volume of new cerebral ischemic lesions
timeFrame: 24-month follow-up
measure: Number of ischemic events
timeFrame: 24-month follow-up
measure: Number of ischemic events
timeFrame: 3-year follow-up
measure: Number of ischemic events
timeFrame: 4-year follow-up
measure: Number of ischemic events
timeFrame: 5-year follow-up
measure: Number of ischemic events
timeFrame: 6-year follow-up
measure: Number of ischemic events
timeFrame: 7-year follow-up
measure: Number of ischemic events
timeFrame: 8-year follow-up
measure: Number of ischemic events
timeFrame: 9-year follow-up
measure: Number of ischemic events
timeFrame: 10-year follow-up
measure: Rate of bleeding
timeFrame: 24-month follow-up
measure: Rate of bleeding
timeFrame: 3-year follow-up
measure: Rate of bleeding
timeFrame: 4-year follow-up
measure: Rate of bleeding
timeFrame: 5-year follow-up
measure: Rate of bleeding
timeFrame: 6-year follow-up
measure: Rate of bleeding
timeFrame: 7-year follow-up
measure: Rate of bleeding
timeFrame: 8-year follow-up
measure: Rate of bleeding
timeFrame: 9-year follow-up
measure: Rate of bleeding
timeFrame: 10-year follow-up
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
References: