<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/NCT03772847</url>
  </required_header>
  <id_info>
    <org_study_id>Yan 2018-015</org_study_id>
    <nct_id>NCT03772847</nct_id>
  </id_info>
  <brief_title>Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial</brief_title>
  <acronym>GIANT</acronym>
  <official_title>Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dongyang People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haiyan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Jiaxing University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongxiang Second People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongxiang First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changxing People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Central Hospital of Lishui City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First People's Hospital of Huzhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taizhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
      Previous clinical studies have confirmed that revascularization or recanalization rate after&#xD;
      intravenous thrombolysis is closely related to the formation of thrombus, which also results&#xD;
      in poor neurological function after thrombolysis. Platelet activating factor (PAF) strong&#xD;
      platelet aggregation may be involved in thrombosis. Formation process. The main components of&#xD;
      Ginkgolide injection (Ginkgo) are ginkgolide, ginkgolides A, ginkgolides B and ginkgolides C.&#xD;
      Ginkgo biloba lactone can antagonize PAF and has strong anti-platelet aggregation. .&#xD;
      Therefore, it can be speculated that ginkgolides injection combined with alteplase&#xD;
      intravenous thrombolysis may improve the recanalization rate after thrombolysis and reduce&#xD;
      the reocclusion rate.&#xD;
&#xD;
      In addition, clinical studies have also found that ginkgolide injection has a good auxiliary&#xD;
      effect on hypertensive intracerebral hemorrhage, which can regulate inflammatory factors such&#xD;
      as IL-6, TNF-α and high-sensitivity C-reactive protein (CRP) in patients. Recovery of&#xD;
      neurological function in patients. It is well known that TNF-α, IL-β, IL-1, IL-6, IFN-γ, etc.&#xD;
      are all inflammatory factors associated with reperfusion injury. Therefore, we speculate that&#xD;
      ginkgolides injection may also regulate inflammatory factors associated with reperfusion&#xD;
      injury, such as IL-6, TNF-α, thereby reducing reperfusion injury, thereby improving patient&#xD;
      prognosis.&#xD;
&#xD;
      The aim of this study was to determine the clinical efficacy of ginkgolides injection&#xD;
      combined with alteplase in the treatment of acute ischemic stroke, and to improve the&#xD;
      prognosis of patients with thrombolysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2</measure>
    <time_frame>90 days</time_frame>
    <description>mRS 0-6, higher indicate worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days</measure>
    <time_frame>14 days</time_frame>
    <description>NIHSS 0-42, and higher indicate worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism）</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1189</enrollment>
  <condition>Intravenous Alteplase Thrombolysis</condition>
  <condition>Neurological Improving</condition>
  <arm_group>
    <arm_group_label>ginkgolide group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ginkgolide plus alteplase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>alteplase</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ginkgolide</intervention_name>
    <description>ginkgolide plus alteplase</description>
    <arm_group_label>ginkgolide group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age over 18 years old, clinically diagnosed as acute ischemic stroke;&#xD;
&#xD;
          2. in accordance with the indications for intravenous thrombolysis;&#xD;
&#xD;
          3. The patient or family member signs an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with transient ischemic attack;&#xD;
&#xD;
          2. Imaging examination of patients with cerebral hemorrhage&#xD;
&#xD;
          3. patients with cerebral arteritis&#xD;
&#xD;
          4. ALT, AST ≥ 3 times the upper limit of normal value, Cr ≥ 1.5 times the upper limit of&#xD;
             normal value&#xD;
&#xD;
          5. There is a tendency to bleed, and severe bleeding has occurred within 3 months&#xD;
&#xD;
          6. Patients with ginkgo drugs, alcohol, glycerol allergies or allergies&#xD;
&#xD;
          7. Patients with pregnancy plans, pregnancy and breastfeeding&#xD;
&#xD;
          8. Patients who participated in other drug clinical studies in the past month&#xD;
&#xD;
          9. Patients considered by the investigator to be unfit to participate in the clinical&#xD;
             study (eg, mental, abnormal, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ze Xin Chen</last_name>
    <role>Study Chair</role>
    <affiliation>2nd affiliated hospital of Zhejiang University，School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Min Lou</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</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/NCT03772847
org study id: Yan 2018-015
nct id: NCT03772847
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Previous clinical studies have confirmed that revascularization or recanalization rate after
      intravenous thrombolysis is closely related to the formation of thrombus, which also results
      in poor neurological function after thrombolysis. Platelet activating factor (PAF) strong
      platelet aggregation may be involved in thrombosis. Formation process. The main components of
      Ginkgolide injection (Ginkgo) are ginkgolide, ginkgolides A, ginkgolides B and ginkgolides C.
      Ginkgo biloba lactone can antagonize PAF and has strong anti-platelet aggregation. .
      Therefore, it can be speculated that ginkgolides injection combined with alteplase
      intravenous thrombolysis may improve the recanalization rate after thrombolysis and reduce
      the reocclusion rate.

      In addition, clinical studies have also found that ginkgolide injection has a good auxiliary
      effect on hypertensive intracerebral hemorrhage, which can regulate inflammatory factors such
      as IL-6, TNF-α and high-sensitivity C-reactive protein (CRP) in patients. Recovery of
      neurological function in patients. It is well known that TNF-α, IL-β, IL-1, IL-6, IFN-γ, etc.
      are all inflammatory factors associated with reperfusion injury. Therefore, we speculate that
      ginkgolides injection may also regulate inflammatory factors associated with reperfusion
      injury, such as IL-6, TNF-α, thereby reducing reperfusion injury, thereby improving patient
      prognosis.

      The aim of this study was to determine the clinical efficacy of ginkgolides injection
      combined with alteplase in the treatment of acute ischemic stroke, and to improve the
      prognosis of patients with thrombolysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2
time frame: 90 days
description: mRS 0-6, higher indicate worse outcome
measure: National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days
time frame: 14 days
description: NIHSS 0-42, and higher indicate worse outcome
measure: recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up
time frame: 3 months
measure: incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism）
time frame: 1 year
arm group label: ginkgolide group
arm group type: Experimental
description: ginkgolide plus alteplase
arm group label: control
arm group type: No Intervention
description: alteplase
intervention type: Drug
intervention name: ginkgolide
description: ginkgolide plus alteplase
arm group label: ginkgolide group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ze Xin Chen
role: Study Chair
affiliation: 2nd affiliated hospital of Zhejiang University，School of Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Ischemic Stroke