<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/NCT04415164</url>
  </required_header>
  <id_info>
    <org_study_id>P2019-08-BDY-08-V04</org_study_id>
    <nct_id>NCT04415164</nct_id>
  </id_info>
  <brief_title>Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke</brief_title>
  <acronym>EXPECT</acronym>
  <official_title>A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Xueshuantong Lyophilized Powder in Chinese Patients With Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dongzhimen Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tianjin University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dongzhimen Hospital, Beijing</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 aim is to assess the effects and harms of Xueshuantong lyophilized powder versus placebo&#xD;
      in patients with acute ischemic stroke when initiated within 72 hours of symptom onset.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2022</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline</measure>
    <time_frame>Day 10 ± 2</time_frame>
    <description>The aim is to assess the effects of Xueshuantong lyophilized powder versus placebo on reducing the neurological impairment when initiated within 72 hours of symptom onset in patients with acute ischemic stroke.&#xD;
The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)</measure>
    <time_frame>Day 10 ± 2</time_frame>
    <description>The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)</measure>
    <time_frame>Day 10 ± 2</time_frame>
    <description>Patient-Reported Outcomes Scale for Stroke, a structured questionnaire-scale was developed suitable for Chinese patients. The score ranges from 0 (best) to 144 (worst).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with modified Rankin Scale grade ≤1 on day 90</measure>
    <time_frame>Day 90 ± 7</time_frame>
    <description>Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS grade between 3 to 6 points are considered to be poor functional outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90</measure>
    <time_frame>Day 90 ± 7</time_frame>
    <description>Barthel Index is a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients measured by Stroke-specific quality of life scale on day 90</measure>
    <time_frame>Day 90 ± 7</time_frame>
    <description>Stroke-Specific Quality of Life Scale is a standardized instrument for evaluating health-related quality of life. The score of 49-item scale with 12 domains range from 49 (worst) to 245 (best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-related adverse events</measure>
    <time_frame>Up to Day 90</time_frame>
    <description>Number of patients with any adverse events during the study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in intercellular adhesion molecule 1 level on day 10 (after the treatment) from baseline</measure>
    <time_frame>Day 10 ± 2</time_frame>
    <description>Level of intercellular adhesion molecule 1 is associated with the clinical outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Interleukin 6 level on day 10 (after the treatment) from baseline</measure>
    <time_frame>Day 10 ± 2</time_frame>
    <description>Level of Interleukin 6 is associated with the clinical outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in tumor necrosis factor-α level on day 10 (after the treatment) from baseline</measure>
    <time_frame>Day 10 ± 2</time_frame>
    <description>Level of tumor necrosis factor-α is associated with the clinical outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in matrix metalloproteinase 9 level on day 10 (after the treatment) from baseline</measure>
    <time_frame>Day 10 ± 2</time_frame>
    <description>Level of matrix metalloproteinase 9 is associated with the clinical outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Xueshuantong</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xueshuantong lyophilized powder</intervention_name>
    <description>Xueshuantong lyophilized powder (500mg), diluted with 250 ml of 0.9% sodium chloride injection, IV (in the vein), once a day, continue for 10 days.</description>
    <arm_group_label>Xueshuantong</arm_group_label>
    <other_name>Zhusheyong Xueshuantong (donggan)</other_name>
    <other_name>WS-10460(ZD-0460)-2002-2011Z</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Guidelines-based standard care</intervention_name>
    <description>Guidelines-based standard care for acute ischemic stroke</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Xueshuantong</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of acute ischemic stroke.&#xD;
&#xD;
          2. Patients that can be treated with study drug within 72 hours of symptoms onset defined&#xD;
             by the &quot;last see normal&quot; principle.&#xD;
&#xD;
          3. 4 ≤ NIHSS score ≤ 16 (total score of upper and lower limbs on motor deficits ≥ 2) at&#xD;
             the randomization time.&#xD;
&#xD;
          4. Female or male aged ≥ 18 years and ≤ 80 years.&#xD;
&#xD;
          5. Provision of signed informed consent prior to any study-specific procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have received intravenous/intra-arterial thrombolysis or mechanical&#xD;
             thrombectomy prior to randomization.&#xD;
&#xD;
          2. Secondary stroke caused by tumor, traumatic brain Injury, hematological disease or&#xD;
             other diseases with the explicit diagnosis.&#xD;
&#xD;
          3. mRS grade ≥ 2 pre-morbid historical assessment.&#xD;
&#xD;
          4. Other conditions that lead to motor dysfunction (e.g. claudication, severe&#xD;
             osteoarthrosis, rheumatoid arthritis, gouty arthritis or other diseases).&#xD;
&#xD;
          5. Known severe impairment of liver function or renal function.&#xD;
&#xD;
          6. Known hypersensitivity to study drugs.&#xD;
&#xD;
          7. Known severe comorbidity with life expectancy &lt; 3 months.&#xD;
&#xD;
          8. Known massive cerebral infarction combined with disturbance of consciousness (1a ≥ 2&#xD;
             in NIHSS), dementia, mental impairment, or unsuitable for participation, in the&#xD;
             opinion of the investigator.&#xD;
&#xD;
          9. Pregnancy or breastfeeding.&#xD;
&#xD;
         10. Participation in another clinical study with an investigational product at any time&#xD;
             during the 3 months prior to randomization (regardless of when treatment with the&#xD;
             investigational product was discontinued).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying Gao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dongzhimen Hospital, Beijing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ying Gao</last_name>
    <phone>0086-010-84013209</phone>
    <email>gaoying973@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luda Feng</last_name>
    <phone>(+86)13051528128</phone>
    <email>luda_feng@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dongzhimen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100700</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luda Feng</last_name>
      <email>luda_feng@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 8, 2021</last_update_submitted>
  <last_update_submitted_qc>April 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dongzhimen Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>Ying Gao</investigator_full_name>
    <investigator_title>President of Institute for Brain Disorders, Beijing University of Chinese Medicine</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>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04415164
org study id: P2019-08-BDY-08-V04
nct id: NCT04415164
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim is to assess the effects and harms of Xueshuantong lyophilized powder versus placebo
      in patients with acute ischemic stroke when initiated within 72 hours of symptom onset.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline
time frame: Day 10 ± 2
description: The aim is to assess the effects of Xueshuantong lyophilized powder versus placebo on reducing the neurological impairment when initiated within 72 hours of symptom onset in patients with acute ischemic stroke.
The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
measure: The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)
time frame: Day 10 ± 2
description: The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
measure: Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)
time frame: Day 10 ± 2
description: Patient-Reported Outcomes Scale for Stroke, a structured questionnaire-scale was developed suitable for Chinese patients. The score ranges from 0 (best) to 144 (worst).
measure: The proportion of patients with modified Rankin Scale grade ≤1 on day 90
time frame: Day 90 ± 7
description: Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS grade between 3 to 6 points are considered to be poor functional outcome.
measure: The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90
time frame: Day 90 ± 7
description: Barthel Index is a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).
measure: Quality of life of patients measured by Stroke-specific quality of life scale on day 90
time frame: Day 90 ± 7
description: Stroke-Specific Quality of Life Scale is a standardized instrument for evaluating health-related quality of life. The score of 49-item scale with 12 domains range from 49 (worst) to 245 (best).
measure: Incidence of treatment-related adverse events
time frame: Up to Day 90
description: Number of patients with any adverse events during the study.
measure: Change in intercellular adhesion molecule 1 level on day 10 (after the treatment) from baseline
time frame: Day 10 ± 2
description: Level of intercellular adhesion molecule 1 is associated with the clinical outcome.
measure: Change in Interleukin 6 level on day 10 (after the treatment) from baseline
time frame: Day 10 ± 2
description: Level of Interleukin 6 is associated with the clinical outcome.
measure: Change in tumor necrosis factor-α level on day 10 (after the treatment) from baseline
time frame: Day 10 ± 2
description: Level of tumor necrosis factor-α is associated with the clinical outcome.
measure: Change in matrix metalloproteinase 9 level on day 10 (after the treatment) from baseline
time frame: Day 10 ± 2
description: Level of matrix metalloproteinase 9 is associated with the clinical outcome.
arm group label: Xueshuantong
arm group type: Experimental
description: Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.
intervention type: Drug
intervention name: Xueshuantong lyophilized powder
description: Xueshuantong lyophilized powder (500mg), diluted with 250 ml of 0.9% sodium chloride injection, IV (in the vein), once a day, continue for 10 days.
arm group label: Xueshuantong
other name: Zhusheyong Xueshuantong (donggan)
other name: WS-10460(ZD-0460)-2002-2011Z
intervention type: Drug
intervention name: Placebo
description: Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.
arm group label: Placebo
intervention type: Other
intervention name: Guidelines-based standard care
description: Guidelines-based standard care for acute ischemic stroke
arm group label: Placebo
arm group label: Xueshuantong
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ying Gao
role: Principal Investigator
affiliation: Dongzhimen Hospital, Beijing
last name: Ying Gao
phone: 0086-010-84013209
email: gaoying973@126.com
last name: Luda Feng
phone: (+86)13051528128
email: luda_feng@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Dongzhimen Hospital, Beijing
investigator full name: Ying Gao
investigator title: President of Institute for Brain Disorders, Beijing University of Chinese Medicine
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No