<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/NCT02259738</url>
  </required_header>
  <id_info>
    <org_study_id>hanying1</org_study_id>
    <nct_id>NCT02259738</nct_id>
  </id_info>
  <brief_title>Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>XuanwuH 2</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Human urinary kallidinogenase can promote the establishment of collateral circulation in the&#xD;
      ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then&#xD;
      increase the perfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute ischemic stroke will be given human urinary kallidinogenase .Then we will&#xD;
      estimate the cerebral collateral circulation in ischemic regions and final infarct volume,&#xD;
      comparing with traditional therapy such as Shuxuening injection, which will provide new&#xD;
      evidence for the treatment of ischemic stroke. Perfusion Weighted Imaging(PWI) could be a&#xD;
      method to reflect the infarction center and low perfusion of tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perfusion Weighted Imaging</measure>
    <time_frame>7 days</time_frame>
    <description>Reflect the infarction center and low perfusion of tissue</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cerebral Infarction</condition>
  <arm_group>
    <arm_group_label>Human urinary kallidinogenase and Shuxuening injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Human Urinary Kallidinogenase</intervention_name>
    <arm_group_label>Human urinary kallidinogenase and Shuxuening injection</arm_group_label>
    <other_name>youruikelin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Shuxuening injection</intervention_name>
    <arm_group_label>Human urinary kallidinogenase and Shuxuening injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:greater than or equal to 18 years old and less than or equal to 70 years old;&#xD;
&#xD;
          -  Time of onset is less than 7 days;&#xD;
&#xD;
          -  Acute cerebral infarction due to the stenosis or occlusion of middle cerebral artery&#xD;
             diagnosed by CT or MRI;&#xD;
&#xD;
          -  The National Institute of Health Stroke Scale(NIHSS) score is 4 to 20;&#xD;
&#xD;
          -  Excluding intracranial hemorrhage using CT or MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The NIHSS score is less than or equal to 3;&#xD;
&#xD;
          -  Patients with cerebral aneurysm, cerebral hemorrhage, brain tumor, brain contusion and&#xD;
             laceration of brain and other diseases;&#xD;
&#xD;
          -  Intracranial hemorrhage displaying by CT or MRI; Cardiac insufficiency;&#xD;
&#xD;
          -  Cardiac insufficiency;&#xD;
&#xD;
          -  Chronic liver disease(A/G inversion),elevated alanine aminotransferase(ALT)(more than&#xD;
             1.5 times the normal value);&#xD;
&#xD;
          -  Increased serum creatinine(more than 1.5 times the normal value);&#xD;
&#xD;
          -  Poorly controlled diabetes;&#xD;
&#xD;
          -  Recently suffered from hemorrhagic disease or bleeding tendency;&#xD;
&#xD;
          -  Recent use of angiotensin-converting enzyme inhibitor (ACEI) drugs;&#xD;
&#xD;
          -  Allergic constitution and had a variety of drug allergy history;&#xD;
&#xD;
          -  Women in period of pregnancy or lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neurolgy,Xuanwu Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>October 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 4, 2014</last_update_submitted>
  <last_update_submitted_qc>October 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>XuanwuH 2</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kallikreins</mesh_term>
  </intervention_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/NCT02259738
org study id: hanying1
nct id: NCT02259738
lead sponsor: 
has dmc: Yes
Human urinary kallidinogenase can promote the establishment of collateral circulation in the
      ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then
      increase the perfusion.
Patients with acute ischemic stroke will be given human urinary kallidinogenase .Then we will
      estimate the cerebral collateral circulation in ischemic regions and final infarct volume,
      comparing with traditional therapy such as Shuxuening injection, which will provide new
      evidence for the treatment of ischemic stroke. Perfusion Weighted Imaging(PWI) could be a
      method to reflect the infarction center and low perfusion of tissue.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Perfusion Weighted Imaging
time frame: 7 days
description: Reflect the infarction center and low perfusion of tissue
arm group label: Human urinary kallidinogenase and Shuxuening injection
arm group type: Experimental
description: Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.
intervention type: Drug
intervention name: Human Urinary Kallidinogenase
arm group label: Human urinary kallidinogenase and Shuxuening injection
other name: youruikelin
intervention type: Drug
intervention name: Shuxuening injection
arm group label: Human urinary kallidinogenase and Shuxuening injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: XuanwuH 2
investigator title: Chief physician
mesh term: Cerebral Infarction
mesh term: Infarction
mesh term: Kallikreins