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/NCT06018181</url>
    </required_header>
    <id_info>
      <org_study_id>2022YFC3501104-01</org_study_id>
      <nct_id>NCT06018181</nct_id>
    </id_info>
    <brief_title>Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice</brief_title>
    <official_title>Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dongzhimen Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        Acute ischemic stroke is one of the main diseases leading to high risk of disability and&#xD;
        morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the&#xD;
        long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset&#xD;
        has been widely recommended by international guidelines.&#xD;
  &#xD;
        Although 35-53% of AIS patients achieve functional independence after receiving IVT, there&#xD;
        are still a large number of patients who are disabled or even dead, and nearly 70% of&#xD;
        patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic&#xD;
        drugs after IVT to further improve the prognosis and reduce the burden of AIS.&#xD;
  &#xD;
        Shuxuetong injection is widely used in China in patients with AIS after IVT, but the&#xD;
        situation in real clinical practice is unclear. Therefore, the study aims to evaluate the&#xD;
        effectiveness and safety of Shuxuetong Injection in patients with AIS treated with&#xD;
        intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>90 Days</target_duration>
    <primary_outcome>
      <measure>Proportion of mRS (0-1)</measure>
      <time_frame>90±7 days</time_frame>
      <description>The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of mRS (0-2)</measure>
      <time_frame>90±7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of mRS (0-1) or returning to baseline</measure>
      <time_frame>90±7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distribution of mRS</measure>
      <time_frame>90±7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of NIHSS</measure>
      <time_frame>baseline, 14 days or the day of discharge</time_frame>
      <description>The change in the National Institute of Health Stroke Scale (NIHSS) scores from baseline to 14 days or the day of discharge. The NIHSS score ranges from 0 (best score) to 42 (worst score).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BI</measure>
      <time_frame>90±7 days</time_frame>
      <description>The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total mortality</measure>
      <time_frame>Within 90 days</time_frame>
      <description>The occurrence of mortality of any cause within 90 days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious Adverse Events</measure>
      <time_frame>Within 90 days</time_frame>
      <description>The occurrence of serious adverse events including any event resulting in prolonged hospital time, permanent damage to the body system or organ, a life-threatening condition or death within 90 days.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2008</enrollment>
    <condition>Ischemic Stroke, Acute</condition>
    <arm_group>
      <arm_group_label>Exposure group</arm_group_label>
      <description>The exposure group was defined as patients receiving Shuxuetong injection and guideline-standardized treatment after intravenous alteplase or tenecteplase.&#xD;
  Mainly based on the following guidelines:(1)Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018; (2)Guidelines for secondary prevention of ischemic stroke and transient ischemic attack in China 2022.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-exposure group</arm_group_label>
      <description>The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Shuxuetong Injection</intervention_name>
      <description>According to clinical real treatment records</description>
      <arm_group_label>Exposure group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours&#xD;
          of onset&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hospitalized patients aged ≥18 years&#xD;
  &#xD;
            -  Diagnosis of acute ischemic stroke&#xD;
  &#xD;
            -  Receiving alteplase or tenecteplase treatment ≤ 4.5 hours of onset&#xD;
  &#xD;
            -  Signed informed consent by patient or legally authorized representatives&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having received or planing to undergo endovascular therapy (including mechanical&#xD;
               thrombectomy, arterial thrombolysis, angioplasty, etc.)&#xD;
  &#xD;
            -  Life expectancy is less than 90 days&#xD;
  &#xD;
            -  Other factors that the researchers think are not suitable for participating in the&#xD;
               research&#xD;
  &#xD;
            -  Currently receiving any experimental treatment&#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_contact>
      <last_name>Mingzhen Qin</last_name>
      <phone>86-17801222857</phone>
      <email>qinmz@bucm.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</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>MD</investigator_title>
    </responsible_party>
    <keyword>Shuxuetong Injection</keyword>
    <keyword>Intravenous Thrombolysis</keyword>
    <keyword>Patient Registry</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Stroke</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/NCT06018181
  org study id: 2022YFC3501104-01
  nct id: NCT06018181
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Acute ischemic stroke is one of the main diseases leading to high risk of disability and
        morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the
        long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset
        has been widely recommended by international guidelines.
  
        Although 35-53% of AIS patients achieve functional independence after receiving IVT, there
        are still a large number of patients who are disabled or even dead, and nearly 70% of
        patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic
        drugs after IVT to further improve the prognosis and reduce the burden of AIS.
  
        Shuxuetong injection is widely used in China in patients with AIS after IVT, but the
        situation in real clinical practice is unclear. Therefore, the study aims to evaluate the
        effectiveness and safety of Shuxuetong Injection in patients with AIS treated with
        intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.
  observational model: Cohort
  time perspective: Prospective
  measure: Proportion of mRS (0-1)
  time frame: 90±7 days
  description: The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).
  measure: Proportion of mRS (0-2)
  time frame: 90±7 days
  measure: Proportion of mRS (0-1) or returning to baseline
  time frame: 90±7 days
  measure: Distribution of mRS
  time frame: 90±7 days
  measure: Change of NIHSS
  time frame: baseline, 14 days or the day of discharge
  description: The change in the National Institute of Health Stroke Scale (NIHSS) scores from baseline to 14 days or the day of discharge. The NIHSS score ranges from 0 (best score) to 42 (worst score).
  measure: BI
  time frame: 90±7 days
  description: The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).
  measure: Total mortality
  time frame: Within 90 days
  description: The occurrence of mortality of any cause within 90 days.
  measure: Serious Adverse Events
  time frame: Within 90 days
  description: The occurrence of serious adverse events including any event resulting in prolonged hospital time, permanent damage to the body system or organ, a life-threatening condition or death within 90 days.
  arm group label: Exposure group
  description: The exposure group was defined as patients receiving Shuxuetong injection and guideline-standardized treatment after intravenous alteplase or tenecteplase.
  Mainly based on the following guidelines:(1)Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018; (2)Guidelines for secondary prevention of ischemic stroke and transient ischemic attack in China 2022.
  arm group label: Non-exposure group
  description: The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase.
  intervention type: Drug
  intervention name: Shuxuetong Injection
  description: According to clinical real treatment records
  arm group label: Exposure group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mingzhen Qin
  phone: 86-17801222857
  email: qinmz@bucm.edu.cn
  responsible party type: Principal Investigator
  investigator affiliation: Dongzhimen Hospital, Beijing
  investigator full name: Ying Gao
  investigator title: MD
  mesh term: Ischemic Stroke
  mesh term: Stroke
  sharing ipd: Undecided