<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/NCT04475835</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF2020LSK-017</org_study_id>
    <nct_id>NCT04475835</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI</brief_title>
  <official_title>Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a randomized, open label, cohort study, in which a total of 100 patients will be&#xD;
      enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during&#xD;
      short-term intervention of non-infarction related artery for acute ST-segment elevation&#xD;
      myocardial infarction after emergency percutaneous coronary intervention.&#xD;
&#xD;
      NACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6&#xD;
      months after recruitment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 2017 guideline gives a class IIA recommendation ('should be considered') for complete&#xD;
      revascularisation in patients presenting with STEMI and multivessel disease, which is&#xD;
      approximately 50% of the STEMI population. Staged multivessel PCI during hospitalization (3-5&#xD;
      days after PPCI) is common in contemporary practice.&#xD;
&#xD;
      Patients undergoing primary PCI should receive enhanced antithrombotic therapy, includes DAPT&#xD;
      and and parenteral anticoagulant, which caused an increased bleeding risk. In addition,&#xD;
      repeated use of heparin in a short time may increase the incidence of HIT. Direct thrombin&#xD;
      inhibitor bivalirudin, demonstrated a reduced risk of bleeding and an overall favorable&#xD;
      profile including reduced NACE.&#xD;
&#xD;
      This is a randomized, open label, cohort study, which is aimed to investigate the safety and&#xD;
      efficacy of bivalirudin during short-term intervention of non-infarction related artery for&#xD;
      acute ST-segment elevation myocardial infarction after emergency percutaneous coronary&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</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>Net adverse clinical events (NACE)</measure>
    <time_frame>30 days</time_frame>
    <description>A composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by BARC definition (grades 1-5).&#xD;
BARC=Bleeding Academic Research Consortium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebral events (MACE)</measure>
    <time_frame>30 days</time_frame>
    <description>A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebral events (MACE)</measure>
    <time_frame>6 months</time_frame>
    <description>A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred.&#xD;
BARC=Bleeding Academic Research Consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>6 months</time_frame>
    <description>Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred.&#xD;
BARC=Bleeding Academic Research Consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>Hospitalization</time_frame>
    <description>Stent thrombosis as defined by ARC ARC=Academic Research Consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>30 days</time_frame>
    <description>Stent thrombosis as defined by ARC ARC=Academic Research Consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>6 months</time_frame>
    <description>Stent thrombosis as defined by ARC ARC=Academic Research Consortium</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>STEMI With Multivessel Coronary Disease</condition>
  <arm_group>
    <arm_group_label>Bivalirudin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bivalirudin with prolonged full dose infusion during PCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Heparin 100U/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bivalirudin</intervention_name>
    <description>Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is &lt;225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.</description>
    <arm_group_label>Bivalirudin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin</intervention_name>
    <description>Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT &lt;225 s (Hemotec method), an intravenous injection of heparin should be administered by need.</description>
    <arm_group_label>Heparin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Acute STEMI (including patients within 12 h of symptom onset, or 24-48 h with&#xD;
             recurrent or ongoing chest pain chest pain, persistent ST-segment elevation or new&#xD;
             left bundle branch block.&#xD;
&#xD;
          -  Staged intervention of non-infarction related artery within 5 days after PPCI during&#xD;
             Hospitalization.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock.&#xD;
&#xD;
          -  Received thrombolytic therapy or used any anticoagulant drugs within 48 hours before&#xD;
             randomized.&#xD;
&#xD;
          -  Active bleeding, recent bleeding events or bleeding tendency.&#xD;
&#xD;
          -  History of surgery in the last 1 month.&#xD;
&#xD;
          -  Suspicious symptoms of aortic dissection, pericarditis and endocarditis.&#xD;
&#xD;
          -  Blood pressure &gt; 180/110 mmHg.&#xD;
&#xD;
          -  Hemoglobin &lt; 100 g/L, Platelet count &lt;100×10(9)/L, Transaminase 3 times upper limit of&#xD;
             normality or Creatinine clearance &lt;30ml/min.&#xD;
&#xD;
          -  History of Heparin-Induced Thrombocytopenia.&#xD;
&#xD;
          -  Allergic to any research drug or device.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Any condition that makes the patient unsuitable for PCI or may interfere with the&#xD;
             study.&#xD;
&#xD;
          -  Patient disagrees or fails to sign the written informed consent.&#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>Yihui Xiao</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yihui Xiao</last_name>
    <phone>+86-18220824850</phone>
    <email>sbw_514@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yihui Xiao</last_name>
      <phone>+86-18220824850</phone>
      <email>sbw_514@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 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>Coronary Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Bivalirudin</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/NCT04475835
org study id: XJTU1AF2020LSK-017
nct id: NCT04475835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, open label, cohort study, in which a total of 100 patients will be
      enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during
      short-term intervention of non-infarction related artery for acute ST-segment elevation
      myocardial infarction after emergency percutaneous coronary intervention.

      NACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6
      months after recruitment.
The 2017 guideline gives a class IIA recommendation ('should be considered') for complete
      revascularisation in patients presenting with STEMI and multivessel disease, which is
      approximately 50% of the STEMI population. Staged multivessel PCI during hospitalization (3-5
      days after PPCI) is common in contemporary practice.

      Patients undergoing primary PCI should receive enhanced antithrombotic therapy, includes DAPT
      and and parenteral anticoagulant, which caused an increased bleeding risk. In addition,
      repeated use of heparin in a short time may increase the incidence of HIT. Direct thrombin
      inhibitor bivalirudin, demonstrated a reduced risk of bleeding and an overall favorable
      profile including reduced NACE.

      This is a randomized, open label, cohort study, which is aimed to investigate the safety and
      efficacy of bivalirudin during short-term intervention of non-infarction related artery for
      acute ST-segment elevation myocardial infarction after emergency percutaneous coronary
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Net adverse clinical events (NACE)
time frame: 30 days
description: A composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by BARC definition (grades 1-5).
BARC=Bleeding Academic Research Consortium
measure: Major adverse cardiac and cerebral events (MACE)
time frame: 30 days
description: A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
measure: Major adverse cardiac and cerebral events (MACE)
time frame: 6 months
description: A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
measure: Bleeding
time frame: 30 days
description: Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred.
BARC=Bleeding Academic Research Consortium
measure: Bleeding
time frame: 6 months
description: Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred.
BARC=Bleeding Academic Research Consortium
measure: Stent thrombosis
time frame: Hospitalization
description: Stent thrombosis as defined by ARC ARC=Academic Research Consortium
measure: Stent thrombosis
time frame: 30 days
description: Stent thrombosis as defined by ARC ARC=Academic Research Consortium
measure: Stent thrombosis
time frame: 6 months
description: Stent thrombosis as defined by ARC ARC=Academic Research Consortium
arm group label: Bivalirudin
arm group type: Experimental
description: Bivalirudin with prolonged full dose infusion during PCI
arm group label: Heparin
arm group type: Active Comparator
description: Heparin 100U/kg
intervention type: Drug
intervention name: Bivalirudin
description: Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.
arm group label: Bivalirudin
intervention type: Drug
intervention name: Heparin
description: Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of heparin should be administered by need.
arm group label: Heparin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yihui Xiao
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Yihui Xiao
phone: +86-18220824850
email: sbw_514@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Coronary Disease
mesh term: Heparin
mesh term: Bivalirudin