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/NCT05996978</url>
    </required_header>
    <id_info>
      <org_study_id>No.2019-112</org_study_id>
      <nct_id>NCT05996978</nct_id>
    </id_info>
    <brief_title>Intensive Drug Therapy for Ischemic Stroke Caused by Severe Intracranial Arterial Stenosis</brief_title>
    <official_title>Intensive Drug Therapy for Ischemic Stroke Caused by Severe Intracranial Arterial Stenosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Yueyang Integrated Medicine Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Yueyang Integrated Medicine Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To observe the safety and efficacy of intensive drug therapy for ischemic stroke caused by&#xD;
        severe intracranial arterial stenosis.Patients with acute stroke caused by intracranial&#xD;
        arterial stenosis (stenosis rate ≥70%) were enrolled and accept dual antiplatelet therapy&#xD;
        (DAPT) (aspirin 100 mg/d and clopidogrel 75 mg/d for 90 days, followed by aspirin 100 mg/d&#xD;
        for long term) under the guidance of platelet function analysis (Verifynow) combined with the&#xD;
        intensive statin therapy (40 mg/d for 14 days, followed by 20 mg/d for long term).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients (35 to 80 years ) with acute ischemic stroke, who can be treated within 72 hours of&#xD;
        symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of&#xD;
        the exclusion criteria will be randomly selected.Patients were treated with dual antiplatelet&#xD;
        therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90&#xD;
        days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for&#xD;
        14 days, followed by 20 mg per day long term) after enrollment. Patients with aspirin&#xD;
        resistance (aspirin reaction units [ARU] ≥550) or clopidogrel resistance (P2Y12 reaction&#xD;
        units [PRU] ≥208) were excluded on the 7th day of therapy.The primary objective is to observe&#xD;
        the safety and efficacy of intensive drug therapy for ischemic stroke patients. A Data and&#xD;
        Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has&#xD;
        been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and&#xD;
        Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2020</start_date>
    <completion_date type="Actual">April 30, 2023</completion_date>
    <primary_completion_date type="Actual">February 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Characteristics of the vessel wall</measure>
      <time_frame>3 years</time_frame>
      <description>The characteristics of the vessel wall were evaluated by high-resolution magnetic resonance imaging (HR-MRI).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The change of the serum LDL-C level</measure>
      <time_frame>24 hours,14 days</time_frame>
      <description>Low-density lipoprotein cholesterol (LDL-C) was tested in the laboratory before and after the treatment.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">42</enrollment>
    <condition>Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>Intensive Drug Therapy</arm_group_label>
      <description>Dual antiplatelet therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90 days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for 14 days, followed by 20 mg per day long term) after enrollment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intensive Drug Therapy</intervention_name>
      <description>Observational only and no predesigned interventions in this study</description>
      <arm_group_label>Intensive Drug Therapy</arm_group_label>
      <other_name>observational only ,no intervention</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 35 and 80 years;&#xD;
  &#xD;
            -  Onset &lt;72 hours;&#xD;
  &#xD;
            -  New-onset ischemic stroke confirmed by skull magnetic resonance diffusion weighted&#xD;
               imaging (MR-DWI);&#xD;
  &#xD;
            -  Severe ICAS (stenosis ≥70%) indicated by time-of-flight magnetic resonance angiography&#xD;
               (TOF-MRA).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ischemic stroke caused by other etiological factors (e.g., cardio-embolism, arterial&#xD;
               dissection, vasculitis, etc.);&#xD;
  &#xD;
            -  Post-infarction hemorrhagic transformation and intraplaque hemorrhage as indicated by&#xD;
               imaging examination;&#xD;
  &#xD;
            -  Contraindications to aspirin, clopidogrel, or atorvastatin;&#xD;
  &#xD;
            -  Intracranial hemorrhage within 3 months and a recent history of surgery or trauma;&#xD;
  &#xD;
            -  Severe organ impairment, liver insufficiency, and renal insufficiency;&#xD;
  &#xD;
            -  Complicated with tumors or hemorrhagic diseases;&#xD;
  &#xD;
            -  Use of drugs forbidden to use in combination after onset, including other antiplatelet&#xD;
               drugs, anticoagulants, thrombolytic drugs, and drugs affecting antiplatelet agents and&#xD;
               statin metabolism.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yan Han, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Shanghai University of Traditional Chinese Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Cerebral Infarction</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <!-- 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/NCT05996978
  org study id: No.2019-112
  nct id: NCT05996978
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To observe the safety and efficacy of intensive drug therapy for ischemic stroke caused by
        severe intracranial arterial stenosis.Patients with acute stroke caused by intracranial
        arterial stenosis (stenosis rate ≥70%) were enrolled and accept dual antiplatelet therapy
        (DAPT) (aspirin 100 mg/d and clopidogrel 75 mg/d for 90 days, followed by aspirin 100 mg/d
        for long term) under the guidance of platelet function analysis (Verifynow) combined with the
        intensive statin therapy (40 mg/d for 14 days, followed by 20 mg/d for long term).
  Patients (35 to 80 years ) with acute ischemic stroke, who can be treated within 72 hours of
        symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of
        the exclusion criteria will be randomly selected.Patients were treated with dual antiplatelet
        therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90
        days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for
        14 days, followed by 20 mg per day long term) after enrollment. Patients with aspirin
        resistance (aspirin reaction units [ARU] ≥550) or clopidogrel resistance (P2Y12 reaction
        units [PRU] ≥208) were excluded on the 7th day of therapy.The primary objective is to observe
        the safety and efficacy of intensive drug therapy for ischemic stroke patients. A Data and
        Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has
        been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and
        Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.
  observational model: Cohort
  time perspective: Prospective
  measure: Characteristics of the vessel wall
  time frame: 3 years
  description: The characteristics of the vessel wall were evaluated by high-resolution magnetic resonance imaging (HR-MRI).
  measure: The change of the serum LDL-C level
  time frame: 24 hours,14 days
  description: Low-density lipoprotein cholesterol (LDL-C) was tested in the laboratory before and after the treatment.
  arm group label: Intensive Drug Therapy
  description: Dual antiplatelet therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90 days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for 14 days, followed by 20 mg per day long term) after enrollment.
  intervention type: Other
  intervention name: Intensive Drug Therapy
  description: Observational only and no predesigned interventions in this study
  arm group label: Intensive Drug Therapy
  other name: observational only ,no intervention
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Yan Han, M.D.
  role: Study Chair
  affiliation: Shanghai University of Traditional Chinese Medicine
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Infarction
  mesh term: Ischemia