xml: <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/NCT06010641</url>
    </required_header>
    <id_info>
      <org_study_id>Y (2023) 148</org_study_id>
      <nct_id>NCT06010641</nct_id>
    </id_info>
    <brief_title>Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)</brief_title>
    <official_title>Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3): a Prospective, Randomized, Open-label, Blinded-endpoint, Multi-center Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>General Hospital of Shenyang Military Region</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>General Hospital of Shenyang Military Region</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>
        The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS)&#xD;
        remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke&#xD;
        with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of&#xD;
        the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate&#xD;
        the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery&#xD;
        atherosclerosis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 21, 2023</start_date>
    <completion_date type="Anticipated">October 21, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 21, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>proportion of favorable functional outcome</measure>
      <time_frame>90±7 days</time_frame>
      <description>favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>proportion of excellent functional outcome</measure>
      <time_frame>90±7 days</time_frame>
      <description>excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ordinal distribution of modified Rankin Score (mRS)</measure>
      <time_frame>90±7 days</time_frame>
      <description>The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>early neurological deterioration (END)</measure>
      <time_frame>48±12 hours</time_frame>
      <description>END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>early neurological improvement (ENI)</measure>
      <time_frame>48±12 hours</time_frame>
      <description>ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in National Institute of Health stroke scale (NIHSS)</measure>
      <time_frame>48±12 hours</time_frame>
      <description>the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in National Institute of Health stroke scale (NIHSS)</measure>
      <time_frame>10±2 days</time_frame>
      <description>the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>changes in infarct volume</measure>
      <time_frame>48±12 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>new stroke or other vascular event(s)</measure>
      <time_frame>90±7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>all-cause mortality</measure>
      <time_frame>90±7 days</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>changes in cortical oxygen saturation determined by near infrared spectroscopy</measure>
      <time_frame>24±8 hours</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>changes in cortical oxygen saturation determined by near infrared spectroscopy</measure>
      <time_frame>48±12 hours</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>changes in serum biomarkers</measure>
      <time_frame>48±12 hours</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>changes in serum biomarkers</measure>
      <time_frame>10±2 days</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Stroke, Acute Ischemic</condition>
    <arm_group>
      <arm_group_label>Head-down position</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>head-down position as an adjunct to guideline-based treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>guideline-based treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>head-down position</intervention_name>
      <description>-20° Trendelenburg as an adjunct to guideline-based treatment,</description>
      <arm_group_label>Head-down position</arm_group_label>
      <arm_group_label>control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old&#xD;
  &#xD;
            -  Acute ischemic stroke confirmed by NCCT or MRI;&#xD;
  &#xD;
            -  Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing&#xD;
               from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours,&#xD;
               requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24&#xD;
               hours;&#xD;
  &#xD;
            -  Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in&#xD;
               Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or&#xD;
               occlusion);&#xD;
  &#xD;
            -  Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral&#xD;
               artery);&#xD;
  &#xD;
            -  First stroke onset or past stroke without obvious neurological deficit (mRS≤2);&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pre-stroke disability (mRS≥3);&#xD;
  &#xD;
            -  Patients with disturbance of consciousness;&#xD;
  &#xD;
            -  Patients who plan to undergo or have completed thrombolysis or mechanical&#xD;
               thrombectomy;&#xD;
  &#xD;
            -  Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;&#xD;
  &#xD;
            -  Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc;&#xD;
  &#xD;
            -  Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection,&#xD;
               moyamoya disease, etc;&#xD;
  &#xD;
            -  Previous history of intracerebral hemorrhage within 1 year;&#xD;
  &#xD;
            -  Any contraindication to head-down position (e.g. active vomiting, pneumonia,&#xD;
               uncontrolled heart failure);&#xD;
  &#xD;
            -  Planned carotid or intracranial revascularization within 3 months;&#xD;
  &#xD;
            -  Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic&#xD;
               blood pressure over 100 mmHg);&#xD;
  &#xD;
            -  Cardiac insufficiency (NYHA Class ≥II);&#xD;
  &#xD;
            -  Pregnant or lactating women;&#xD;
  &#xD;
            -  Comorbidity with other serious diseases;&#xD;
  &#xD;
            -  Participating in other clinical trials within 3 months;&#xD;
  &#xD;
            -  Patients not suitable for the study considered by researcher.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Neurology, General Hospital of Northern Theater Command</name>
        <address>
          <city>Shenyang</city>
          <zip>110016</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>General Hospital of Shenyang Military Region</investigator_affiliation>
      <investigator_full_name>Hui-Sheng Chen</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <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>Atherosclerosis</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010641
  org study id: Y (2023) 148
  nct id: NCT06010641
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS)
        remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke
        with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of
        the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate
        the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery
        atherosclerosis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: proportion of favorable functional outcome
  time frame: 90±7 days
  description: favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
  measure: proportion of excellent functional outcome
  time frame: 90±7 days
  description: excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
  measure: ordinal distribution of modified Rankin Score (mRS)
  time frame: 90±7 days
  description: The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
  measure: early neurological deterioration (END)
  time frame: 48±12 hours
  description: END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage
  measure: early neurological improvement (ENI)
  time frame: 48±12 hours
  description: ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
  measure: Changes in National Institute of Health stroke scale (NIHSS)
  time frame: 48±12 hours
  description: the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
  measure: Changes in National Institute of Health stroke scale (NIHSS)
  time frame: 10±2 days
  description: the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
  measure: changes in infarct volume
  time frame: 48±12 hours
  measure: new stroke or other vascular event(s)
  time frame: 90±7 days
  measure: all-cause mortality
  time frame: 90±7 days
  measure: changes in cortical oxygen saturation determined by near infrared spectroscopy
  time frame: 24±8 hours
  measure: changes in cortical oxygen saturation determined by near infrared spectroscopy
  time frame: 48±12 hours
  measure: changes in serum biomarkers
  time frame: 48±12 hours
  measure: changes in serum biomarkers
  time frame: 10±2 days
  arm group label: Head-down position
  arm group type: Experimental
  description: head-down position as an adjunct to guideline-based treatment
  arm group label: control
  arm group type: Other
  description: guideline-based treatment
  intervention type: Other
  intervention name: head-down position
  description: -20° Trendelenburg as an adjunct to guideline-based treatment,
  arm group label: Head-down position
  arm group label: control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: General Hospital of Shenyang Military Region
  investigator full name: Hui-Sheng Chen
  investigator title: Director
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Atherosclerosis
  mesh term: Ischemia
  sharing ipd: Undecided