<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/NCT03822975</url>
  </required_header>
  <id_info>
    <org_study_id>2018-031</org_study_id>
    <nct_id>NCT03822975</nct_id>
  </id_info>
  <brief_title>Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI</brief_title>
  <acronym>BRIGHT-4</acronym>
  <official_title>Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenyang Northern Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenyang Northern Hospital</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>
      This study is aimed to investigate if the bivaliruding with prolonged full dose infusion&#xD;
      after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for&#xD;
      patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be&#xD;
      enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a&#xD;
      1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy&#xD;
      decisions in STEMI patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Anticipated">May 6, 2023</completion_date>
  <primary_completion_date type="Actual">May 7, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of all-cause death or BARC type 3~5 bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>BARC=Bleeding academic research consortium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BARC type 3-5 bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>BARC=Bleeding academic research consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebral events (MACE)</measure>
    <time_frame>30 days</time_frame>
    <description>MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net adverse clinical events (NACE)</measure>
    <time_frame>30 days</time_frame>
    <description>NACE is defined as a composite of MACE or BARC type 3-5 bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of all-cause death or BARC type 2-5 bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>BARC=Bleeding academic research consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BARC type 2-5 bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>BARC=Bleeding academic research consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>30 days</time_frame>
    <description>Definite or probable stent thrombosis according to Academic Research Consortium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombocytopenia</measure>
    <time_frame>30 days</time_frame>
    <description>defined as platelet counts less than 150*10^9/L after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>1 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6016</enrollment>
  <condition>ST Elevation Myocardial Infarction</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 primary PCI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Heparin alone during primary PCI</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 2-4 hours after PCI. 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 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is &gt;225 seconds.</description>
    <arm_group_label>Bivalirudin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>unfractionated Heparin</intervention_name>
    <description>Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT &lt;225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is &gt;225 seconds.</description>
    <arm_group_label>Heparin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any age;&#xD;
&#xD;
          -  STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or&#xD;
             new LBBB with symptom onset 48h;&#xD;
&#xD;
          -  Patients requiring staged revascularization of non-culprit vessels within 30 days may&#xD;
             be enrolled. In such cases the same antithrombotic agents and PCI procedures must be&#xD;
             used in the staged procedure consistent with the index procedure PCI, in particular&#xD;
             the assigned antithrombin agent heparin vs. bivalirudin);&#xD;
&#xD;
          -  Dual antiplatelet drugs must be administrated according to guidelines before PCI&#xD;
             (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor);&#xD;
&#xD;
          -  The subject or legal representative has been informed of the nature of the study,&#xD;
             understood the provisions of the protocol, was able to ensure adherence, and signed&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not suitable for emergency primary PCI;&#xD;
&#xD;
          -  STEMI treated by thrombolysis;&#xD;
&#xD;
          -  Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours&#xD;
             before the index PCI;&#xD;
&#xD;
          -  Mechanical complications (such as ventricular septal rupture, papillary muscle rupture&#xD;
             with acute mitral regurgitation, etc.);&#xD;
&#xD;
          -  Known allergy or contraindications to heparin, bivalirudin, aspirin, or both&#xD;
             clopidogrel and ticagrelor&#xD;
&#xD;
          -  Patients in whom the investigators consider inappropriate to participate in this study&#xD;
             (eg, have participated in another drug/instrument study or undergoing another&#xD;
             drug/instrument study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaling Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The General Hospital of Northern Theater Command</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bengbu Second People's Hospital</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fu Yang People'S Hospital</name>
      <address>
        <city>Fuyang</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linquan County Peoples Hospital</name>
      <address>
        <city>Fuyang</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NO.2 People's Hospital of Fuyang City</name>
      <address>
        <city>Fuyang</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taihe County People'S Hospital</name>
      <address>
        <city>Fuyang</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bozhou Peoples Hospital</name>
      <address>
        <city>Haozhou</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huainan Oriental Hospital Group Affiliated Hospital of Anhui University of Science &amp; Technology</name>
      <address>
        <city>Huainan</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Anhui University of Science&amp;Technology</name>
      <address>
        <city>Huainan</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suzhou Municipal Hospital</name>
      <address>
        <city>Suzhou</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Luhe Hospital.Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital Yanqing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing University Fuling Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meizhou Peopie's Hospital</name>
      <address>
        <city>Meizhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yulin First People's Hospital</name>
      <address>
        <city>Yulin</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Guizhou Medical University</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital Ofzunyi Medical University</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hengshuicardiovascularhospital</name>
      <address>
        <city>Hengshui</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiaozuo People's Hospital</name>
      <address>
        <city>Jiaozuo</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaifeng Central Hospital</name>
      <address>
        <city>Kaifeng</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luohe Central Hospital</name>
      <address>
        <city>Luohe</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People'S Hospital of Ruzhou</name>
      <address>
        <city>Ruzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shangqiu first people's Hospital</name>
      <address>
        <city>Shangqiu</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital Of Xinxiang Medical University</name>
      <address>
        <city>Xinxiang</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuzhoucitypeopleshospital</name>
      <address>
        <city>Yuzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuwai Central China Cardiovascular Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University Center 1</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University Center 2</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People'S Hospital of Xinmi</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Itchoshtal Tonjinee Colere Hoatono Innehatyor Seene Ano Thohholdcy</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital Tongji Medical College of Hust</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhanasia Heart Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lou Di Central Hospital</name>
      <address>
        <city>Loudi</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangtan Central Hospital</name>
      <address>
        <city>Xiangtan</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yueyang Central Hospital</name>
      <address>
        <city>Yueyang</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chifeng College Affiliated Hospital</name>
      <address>
        <city>Chifeng</city>
        <state>Inner Mongolia</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Firsthospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsutaizhou Peoples Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital Of Gannan Medical University</name>
      <address>
        <city>Ganzhou</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganzhou Municipal Hospital</name>
      <address>
        <city>Ganzhou</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nan Fang Hospital.Ganzhou</name>
      <address>
        <city>Ganzhou</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jiangxi Provincial People's Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thefirstaffiliated Hospitalofnanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China-Japan Union Hospital of Jilin University</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Jilin University</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yanbian University Hospital</name>
      <address>
        <city>Yanbian</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Benxi Iron &amp; Steel Industry Group of Liaoning Health Industry Group</name>
      <address>
        <city>Benxi</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalian No.3 People'S Hospital</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangpiqiao99@sina.com</name>
      <address>
        <city>Diaobingshan</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fushun Central Hospital</name>
      <address>
        <city>Fushun</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Fushun Mining Industry Group of Liaoning Health Industry Group</name>
      <address>
        <city>Fushun</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group</name>
      <address>
        <city>Fuxin</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Northern Theater Command</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fourth Affiliated Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Shen Yang Medical College</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heze Mudan People's Hospital</name>
      <address>
        <city>Heze</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heze Municipal Hospital</name>
      <address>
        <city>Heze</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jinan Central Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Scend Provincial General Hosptial</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fifth People's Hospital of Jinan</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qingdao Municipal Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taian City Central Hospital</name>
      <address>
        <city>Tai'an</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The People's Hospital ofXin Tai City</name>
      <address>
        <city>Xintai</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zao Zhuang Central Hospital Of Shandong Guoxin Healthcare Group</name>
      <address>
        <city>Zaozhuang</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Datong Third People'S Hospiatl</name>
      <address>
        <city>Datong</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Cardiovascular Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, Tangdu Hospital, Airforce Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Amliated HospitalofNorthwest University Xi'an No.3 Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Of Xian Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yan 'an university Affiliated Hospital</name>
      <address>
        <city>Yanan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Liangshan</name>
      <address>
        <city>Xichang</city>
        <state>Sichaun</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The People's Hospital Of Pingchang</name>
      <address>
        <city>Bazhong</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;West China Hospital Sichuan University&quot;</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chengdu Second People'S Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Chengdu University of TCM</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University</name>
      <address>
        <city>Luzhou</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi Chang People'S Hospital</name>
      <address>
        <city>Xichang</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Chest Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fifth Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Ürümqi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yunnan St.John'S Hospital</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou Central Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenyang Northern Hospital</investigator_affiliation>
    <investigator_full_name>Han Yaling</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Primary percutaneous coronary intervention</keyword>
  <keyword>anticoagulant agents</keyword>
  <keyword>bivalirudin</keyword>
  <keyword>heparin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial 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>Heparin</mesh_term>
    <mesh_term>Calcium heparin</mesh_term>
    <mesh_term>Bivalirudin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03822975
org study id: 2018-031
nct id: NCT03822975
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is aimed to investigate if the bivaliruding with prolonged full dose infusion
      after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for
      patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be
      enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a
      1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy
      decisions in STEMI patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Composite of all-cause death or BARC type 3~5 bleeding
time frame: 30 days
description: BARC=Bleeding academic research consortium
measure: All cause mortality
time frame: 30 days
measure: BARC type 3-5 bleeding
time frame: 30 days
description: BARC=Bleeding academic research consortium
measure: Major adverse cardiac and cerebral events (MACE)
time frame: 30 days
description: MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
measure: Net adverse clinical events (NACE)
time frame: 30 days
description: NACE is defined as a composite of MACE or BARC type 3-5 bleeding
measure: Composite of all-cause death or BARC type 2-5 bleeding
time frame: 30 days
description: BARC=Bleeding academic research consortium
measure: BARC type 2-5 bleeding
time frame: 30 days
description: BARC=Bleeding academic research consortium
measure: Stent thrombosis
time frame: 30 days
description: Definite or probable stent thrombosis according to Academic Research Consortium
measure: Thrombocytopenia
time frame: 30 days
description: defined as platelet counts less than 150*10^9/L after treatment
measure: All cause mortality
time frame: 1 years
arm group label: Bivalirudin
arm group type: Experimental
description: Bivalirudin with prolonged full dose infusion during primary PCI
arm group label: Heparin
arm group type: Active Comparator
description: Heparin alone during primary PCI
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 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds.
arm group label: Bivalirudin
intervention type: Drug
intervention name: unfractionated Heparin
description: Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is >225 seconds.
arm group label: Heparin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yaling Han, MD
role: Principal Investigator
affiliation: The General Hospital of Northern Theater Command
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country: China
responsible party type: Principal Investigator
investigator affiliation: Shenyang Northern Hospital
investigator full name: Han Yaling
investigator title: Director
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
mesh term: Heparin
mesh term: Calcium heparin
mesh term: Bivalirudin
sharing ipd: No