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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Patent Foramen Ovale; Bleeding Ulcer
• Intervention / Treatment: Other: Antiplatelet treatment discontinuation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Cote, MSc; Phone Number: 14186537270; Email: melanie.cote@criucpq.ulaval.ca
• Study Contact Backup: Name: Josep Rodes-Cabau, MD; Phone Number: 4186568711; Email: josep.rodes@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Recruiting
    • IUCPQ
    • Contact: Melanie Cote, MSc; Phone Number: Rodes-Cabau 4186568711; Email: josep.rodes@criucpq.ulaval.ca
    • Principal Investigator: Josep Rodés-Cabau, MD
    • Contact: Josep Rodes-Cabau, MD; Phone Number: 4186568711; Email: josep.rodes@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antiplatelet treatment discontinuation; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Presence of new ischemic lesions	Evaluated by MRI	24-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of new cerebral ischemic lesions	Evaluated by MRI	24-month follow-up
Volume of new cerebral ischemic lesions	Evaluated by MRI	24-month follow-up
Number of ischemic events	Stroke, TIA	24-month follow-up
Number of ischemic events	Stroke, TIA	3-year follow-up
Number of ischemic events	Stroke, TIA	4-year follow-up
Number of ischemic events	Stroke, TIA	5-year follow-up
Number of ischemic events	Stroke, TIA	6-year follow-up
Number of ischemic events	Stroke, TIA	7-year follow-up
Number of ischemic events	Stroke, TIA	8-year follow-up
Number of ischemic events	Stroke, TIA	9-year follow-up
Number of ischemic events	Stroke, TIA	10-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	24-month follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	3-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	4-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	5-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	6-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	7-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	8-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	9-year follow-up
Rate of bleeding	Life-threatening, major or minor bleeding	10-year follow-up

Collaborators and Investigators

• Sponsor: Josep Rodes-Cabau

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2032

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Bleeding; Ischemic Stroke; Transcatheter Patent Foramen Ovale (PFO) closure; Young patients
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Stroke; Ischemic Stroke; Hemorrhage; Foramen Ovale, Patent
• Other Study ID Numbers: HALTI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No