<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04475510</url>
  </required_header>
  <id_info>
    <org_study_id>HALTI</org_study_id>
    <nct_id>NCT04475510</nct_id>
  </id_info>
  <brief_title>Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke</brief_title>
  <acronym>HALTI</acronym>
  <official_title>Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Josep Rodes-Cabau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut universitaire de cardiologie et de pneumologie de Québec, University Laval</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the safety of antithrombotic treatment discontinuation 12 months following&#xD;
      successful transcatheter PFO closure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit&#xD;
      a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term&#xD;
      follow-up, eventually exceeding the risk of ischemic events.&#xD;
&#xD;
      Importantly, the vast majority of major bleeding events seem to occur in patients receiving&#xD;
      antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is&#xD;
      not associated with any increase in ischemic events, and could potentially translate into a&#xD;
      lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that&#xD;
      in young patients without any other comorbidities increasing the risk of stroke, shorter-term&#xD;
      (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO&#xD;
      closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2032</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of new stroke events</measure>
    <time_frame>12 months</time_frame>
    <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 &lt; 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of new ischemic lesions</measure>
    <time_frame>24-month follow-up</time_frame>
    <description>Evaluated by MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of new cerebral ischemic lesions</measure>
    <time_frame>24-month follow-up</time_frame>
    <description>Evaluated by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of new cerebral ischemic lesions</measure>
    <time_frame>24-month follow-up</time_frame>
    <description>Evaluated by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>24-month follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>3-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>4-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>5-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>6-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>7-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>8-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>9-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ischemic events</measure>
    <time_frame>10-year follow-up</time_frame>
    <description>Stroke, TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>24-month follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>3-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>4-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>5-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>6-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>7-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>8-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>9-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>10-year follow-up</time_frame>
    <description>Life-threatening, major or minor bleeding</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Patent Foramen Ovale</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Bleeding Ulcer</condition>
  <arm_group>
    <arm_group_label>Antiplatelet treatment discontinuation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Antiplatelet treatment discontinuation</intervention_name>
    <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.</description>
    <arm_group_label>Antiplatelet treatment discontinuation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Successful transcatheter PFO closure with any approved device&#xD;
&#xD;
          -  Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone&#xD;
             successful transcatheter PFO closure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&gt;60 year-old&#xD;
&#xD;
          -  RoPE score &lt;6&#xD;
&#xD;
          -  Residual shunt ≥moderate following PFO closure&#xD;
&#xD;
          -  Atrial fibrillation following PFO closure&#xD;
&#xD;
          -  Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus&#xD;
             anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S&#xD;
             deficiency)&#xD;
&#xD;
          -  Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure&#xD;
&#xD;
          -  Failure to provide signed informed consent&#xD;
&#xD;
          -  Absolute contraindications for an MRI study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Josep Rodes-Cabau, MD</last_name>
    <phone>4186568711</phone>
    <email>josep.rodes@criucpq.ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Melanie Cote, MSc</last_name>
    <phone>14186537270</phone>
    <email>melanie.cote@criucpq.ulaval.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IUCPQ</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josep Rodes-Cabau, MD</last_name>
      <phone>4186568711</phone>
      <email>josep.rodes@criucpq.ulaval.ca</email>
    </contact>
    <contact_backup>
      <last_name>Melanie Cote, MSc</last_name>
      <phone>4186568711</phone>
      <phone_ext>Rodes-Cabau</phone_ext>
      <email>josep.rodes@criucpq.ulaval.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Josep Rodes-Cabau, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Institut universitaire de cardiologie et de pneumologie de Québec, University Laval</investigator_affiliation>
    <investigator_full_name>Josep Rodes-Cabau</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transcatheter Patent Foramen Ovale (PFO) closure</keyword>
  <keyword>Ischemic Stroke</keyword>
  <keyword>Bleeding</keyword>
  <keyword>Young patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Foramen Ovale, Patent</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04475510
org study id: HALTI
nct id: NCT04475510
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To determine the safety of antithrombotic treatment discontinuation 12 months following
      successful transcatheter PFO closure.
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.
allocation: N/A
intervention model: Single Group Assignment
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
masking: None (Open Label)
measure: Presence of new stroke events
time frame: 12 months
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.
measure: Presence of new ischemic lesions
time frame: 24-month follow-up
description: Evaluated by MRI
measure: Number of new cerebral ischemic lesions
time frame: 24-month follow-up
description: Evaluated by MRI
measure: Volume of new cerebral ischemic lesions
time frame: 24-month follow-up
description: Evaluated by MRI
measure: Number of ischemic events
time frame: 24-month follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 3-year follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 4-year follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 5-year follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 6-year follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 7-year follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 8-year follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 9-year follow-up
description: Stroke, TIA
measure: Number of ischemic events
time frame: 10-year follow-up
description: Stroke, TIA
measure: Rate of bleeding
time frame: 24-month follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 3-year follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 4-year follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 5-year follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 6-year follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 7-year follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 8-year follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 9-year follow-up
description: Life-threatening, major or minor bleeding
measure: Rate of bleeding
time frame: 10-year follow-up
description: Life-threatening, major or minor bleeding
arm group label: Antiplatelet treatment discontinuation
arm group type: Experimental
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: Antiplatelet treatment discontinuation
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.
arm group label: Antiplatelet treatment discontinuation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Josep Rodes-Cabau, MD
phone: 4186568711
email: josep.rodes@criucpq.ulaval.ca
last name: Melanie Cote, MSc
phone: 14186537270
email: melanie.cote@criucpq.ulaval.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
investigator full name: Josep Rodes-Cabau
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Foramen Ovale, Patent
mesh term: Hemorrhage