Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke

Ischemic Stroke Clinical Trial

— HALTI  

Official title:

Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475510
• Other study ID #: HALTI
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: August 1, 2032

Study information

• Verified date: June 2023
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: Josep Rodes-Cabau, MD
• Phone: 4186568711
• Email: josep.rodes[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2032
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Ulcer
• Foramen Ovale, Patent
• Hemorrhage
• Ischemic Stroke
• Patent Foramen Ovale
• Stroke

Intervention

Other:
• Antiplatelet treatment discontinuation
All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Josep Rodes-Cabau

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	Presence of new ischemic lesions	Evaluated by MRI	24-month follow-up
Secondary	Number of new cerebral ischemic lesions	Evaluated by MRI	24-month follow-up
Secondary	Volume of new cerebral ischemic lesions	Evaluated by MRI	24-month follow-up
Secondary	Number of ischemic events	Stroke, TIA	24-month follow-up
Secondary	Number of ischemic events	Stroke, TIA	3-year follow-up
Secondary	Number of ischemic events	Stroke, TIA	4-year follow-up
Secondary	Number of ischemic events	Stroke, TIA	5-year follow-up
Secondary	Number of ischemic events	Stroke, TIA	6-year follow-up
Secondary	Number of ischemic events	Stroke, TIA	7-year follow-up
Secondary	Number of ischemic events	Stroke, TIA	8-year follow-up
Secondary	Number of ischemic events	Stroke, TIA	9-year follow-up
Secondary	Number of ischemic events	Stroke, TIA	10-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	24-month follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	3-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	4-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	5-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	6-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	7-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	8-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	9-year follow-up
Secondary	Rate of bleeding	Life-threatening, major or minor bleeding	10-year follow-up