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

Primary Purpose

Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Antiplatelet treatment discontinuation
Sponsored by
Josep Rodes-Cabau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patent Foramen Ovale focused on measuring Transcatheter Patent Foramen Ovale (PFO) closure, Ischemic Stroke, Bleeding, Young patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IUCPQRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antiplatelet treatment discontinuation

Arm 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.

Outcomes

Primary Outcome Measures

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.
Presence of new ischemic lesions
Evaluated by MRI

Secondary Outcome Measures

Number of new cerebral ischemic lesions
Evaluated by MRI
Volume of new cerebral ischemic lesions
Evaluated by MRI
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding
Rate of bleeding
Life-threatening, major or minor bleeding

Full Information

First Posted
July 14, 2020
Last Updated
June 8, 2023
Sponsor
Josep Rodes-Cabau
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1. Study Identification

Unique Protocol Identification Number
NCT04475510
Brief Title
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Acronym
HALTI
Official Title
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josep Rodes-Cabau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer
Keywords
Transcatheter Patent Foramen Ovale (PFO) closure, Ischemic Stroke, Bleeding, Young patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antiplatelet treatment discontinuation
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Antiplatelet treatment discontinuation
Intervention Description
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 Outcome Measure Information:
Title
Presence of new stroke events
Description
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.
Time Frame
12 months
Title
Presence of new ischemic lesions
Description
Evaluated by MRI
Time Frame
24-month follow-up
Secondary Outcome Measure Information:
Title
Number of new cerebral ischemic lesions
Description
Evaluated by MRI
Time Frame
24-month follow-up
Title
Volume of new cerebral ischemic lesions
Description
Evaluated by MRI
Time Frame
24-month follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
24-month follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
3-year follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
4-year follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
5-year follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
6-year follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
7-year follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
8-year follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
9-year follow-up
Title
Number of ischemic events
Description
Stroke, TIA
Time Frame
10-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
24-month follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
3-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
4-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
5-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
6-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
7-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
8-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
9-year follow-up
Title
Rate of bleeding
Description
Life-threatening, major or minor bleeding
Time Frame
10-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Rodes-Cabau, MD
Phone
4186568711
Email
josep.rodes@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Cote, MSc
Phone
14186537270
Email
melanie.cote@criucpq.ulaval.ca
Facility Information:
Facility Name
IUCPQ
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Rodes-Cabau, MD
Phone
4186568711
Email
josep.rodes@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Melanie Cote, MSc
Phone
4186568711
Ext
Rodes-Cabau
Email
josep.rodes@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Josep Rodes-Cabau, MD

12. IPD Sharing Statement

Learn more about this trial

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

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