<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/NCT01696110</url>
  </required_header>
  <id_info>
    <org_study_id>SYNH20120001</org_study_id>
    <secondary_id>2011BAI11B07</secondary_id>
    <nct_id>NCT01696110</nct_id>
  </id_info>
  <brief_title>BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.</brief_title>
  <acronym>BRIGHT</acronym>
  <official_title>Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three&#xD;
      antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or&#xD;
      unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.&#xD;
&#xD;
      All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of&#xD;
      the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, single-blind, active drug controlled multicenter clinical&#xD;
      research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous&#xD;
      coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or&#xD;
      unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa&#xD;
      inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The&#xD;
      purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients&#xD;
      with DES.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net Adverse Clinical Events</measure>
    <time_frame>30 days</time_frame>
    <description>A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Net adverse clinical events</measure>
    <time_frame>1 year</time_frame>
    <description>a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>any bleedings (BARC class)</measure>
    <time_frame>30 day</time_frame>
    <description>including all BARC class (class 1-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebral events (MACCE)</measure>
    <time_frame>30 days and 1 year</time_frame>
    <description>a composite of all cause death, reinfarction, target vessel revascularization or stroke</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Thrombocytopenia</measure>
    <time_frame>30 days</time_frame>
    <description>Defined as a decrease of platelet count of more than 50% or more than 150000 platelet/mm3 compared with baseline within 24h after study drug administration</description>
  </other_outcome>
  <other_outcome>
    <measure>stent thrombosis</measure>
    <time_frame>30 days and 1 year</time_frame>
    <description>by ARC definition</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2194</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Bivalirudin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT&lt;225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heparin monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 IU/kg intravenous bolus. If ACT &lt;225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>heparin plus tirofiban</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bivalirudin</intervention_name>
    <description>Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.</description>
    <arm_group_label>Bivalirudin</arm_group_label>
    <other_name>Taijianing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>heparin</intervention_name>
    <description>heparin monotherapy</description>
    <arm_group_label>Heparin monotherapy</arm_group_label>
    <arm_group_label>heparin plus tirofiban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>heparin plus tirofiban</intervention_name>
    <description>combined use of heparin and tirofiban during PCI</description>
    <arm_group_label>heparin plus tirofiban</arm_group_label>
    <other_name>brand name of tirofiban: Xinweining</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 80 years old&#xD;
&#xD;
          2. Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset&#xD;
             within 12h for STEMI (or within 24 h for patients have unrelieved chest pain,&#xD;
             continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI&#xD;
&#xD;
          3. Avoid to undergoing revascularization for non-culprit vessels within 30 days after&#xD;
             index procedure.&#xD;
&#xD;
          4. Provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation&#xD;
             myocardial infarction; left main coronary artery disease; cardiogenic shock.&#xD;
&#xD;
          2. Any anticoagulant agents were used 48 h before randomization.&#xD;
&#xD;
          3. Active bleeding or bleeding constitution, bleeding tendency, including the recent&#xD;
             retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months),&#xD;
             cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.;&#xD;
&#xD;
          4. Other disease may lead to vascular lesions and secondary bleeding factors (such as&#xD;
             active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),&#xD;
&#xD;
          5. Deep puncture or major surgery (including eye or brain surgery) within 1 month.&#xD;
&#xD;
          6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.&#xD;
&#xD;
          7. Untreated or uncontrolled hypertension &gt; 180/110 mmHg.&#xD;
&#xD;
          8. Hemoglobin &lt; 100 g/L or platelet count &lt; 100 * 109 / L.&#xD;
&#xD;
          9. Elevated AST, ALT level higher than three times of the normal upper limit.&#xD;
&#xD;
         10. severe renal insufficiency (eGFR &lt; 30 mL/min / 1.73 m2).&#xD;
&#xD;
         11. Heparin induced thrombocytopenia.&#xD;
&#xD;
         12. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and&#xD;
             clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.&#xD;
&#xD;
         13. Pregnancy or lactation.&#xD;
&#xD;
         14. Researchers think that doesn't fit to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaling Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shenyang Northern Hospital,China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1 st Hosp. of Anhui Med Univ.</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hosp.</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>3rd Hosp. of Beijing Univ.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Anzhen Hosp.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing CAPF General Hosp.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Chaoyang Hosp.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hosp.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing General Hosp. of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hosp.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Luhe Hosp.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hosp of PLA (1)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hosp. of PLA(2)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Navy General Hosp. of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.304 Hosp. of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.306 Hosp. of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Univ. First Hosp.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 2nd artillery general Hosp. of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing Daping Hosp.</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Med Univ. Uion Hosp.</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1 st Hosp. of Lanzhou Univ.</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lanzhou General Hosp. of PLA</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1 st Hosp. of Guangzhou MU</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Hosp. of Zhongshan MU</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hosp.</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou General Hosp. of PLA</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1 st Hosp. of Guangxi Med Univ.</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.252 Hosp. of PLA</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cangzhou Centeral Hosp.</name>
      <address>
        <city>Cangzhou</city>
        <state>Hebei</state>
        <zip>061000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qinhuangdao No.1 Hosp.</name>
      <address>
        <city>Qinhuangdao</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hebei General Hosp.</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shijiazhuang Peace Hosp.</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangshan Gongren Hosp.</name>
      <address>
        <city>Tangshan</city>
        <state>Hebei</state>
        <zip>063000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daqing General Hosp. of OF.</name>
      <address>
        <city>Daqing</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.152 Hosp.</name>
      <address>
        <city>Pingdingshan</city>
        <state>Henan</state>
        <zip>467000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Asican Heart Hosp.</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan General Hosp of PLA</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing First Hosp.</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuzhou Med Col. Affiliated Hosp.</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuzhou No.4 Hosp.</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2 nd Hosp. of Nanchang Univ.</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Hosp of Jilin Univ.</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2nd Hosp of Jilin Univ.</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>3rd Hosp of Jilin Univ.</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meihekou Central Hosp.</name>
      <address>
        <city>Meihekou</city>
        <state>Jilin</state>
        <zip>135000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalian Zhongshan Hosp.</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.210 Hosp of PLA</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.313 Hosp. of PLA</name>
      <address>
        <city>Huludao</city>
        <state>Liaoning</state>
        <zip>125000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Hosp. of Liaoning MC</name>
      <address>
        <city>Jinzhou</city>
        <state>Liaoning</state>
        <zip>121000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>3 rd Hosp. of Liaoning Med Col.</name>
      <address>
        <city>Jinzhou</city>
        <state>Liaoning</state>
        <zip>121000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.463 Hosp of PLA</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhou Hosp. of SMC</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yingkou Centeral Hosp.</name>
      <address>
        <city>Yingkou</city>
        <state>Liaoning</state>
        <zip>115000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hosp. of Ningxia MU</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ji'nan General Hosp. of PLA</name>
      <address>
        <city>Ji'nan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hosp. of Jining MC</name>
      <address>
        <city>Jining</city>
        <state>Shandong</state>
        <zip>272000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taian Central Hosp.</name>
      <address>
        <city>Taian</city>
        <state>Shandong</state>
        <zip>271000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yantaishan Hosp.</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <zip>261400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No. 148 Hosp.</name>
      <address>
        <city>Zibo</city>
        <state>Shandong</state>
        <zip>255000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hosp.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai jingan people's hosp.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Renji Hosp.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Hosp. of Shanxi Med Univ.</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Cardiovascular Hosp.</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taiyuan Central Hosp.</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2 nd Hosp. of Xi'an Med Col.</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi General Hosp. of CAPF</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi General Hosp.</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangdu Hosp.</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xijing Hosp.</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yanan Univ. affiliated Hosp.</name>
      <address>
        <city>Yanan</city>
        <state>Shanxi</state>
        <zip>716000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuncheng Central Hosp.</name>
      <address>
        <city>Yuncheng</city>
        <state>Shanxi</state>
        <zip>044000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chengdu General Hosp. of PLA</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chengdu No.2 Hosp.</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.254 Hosp. of PLA</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin CAPF Hosp.</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Chest Hosp.</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin No.3 Hosp.</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin People's Hosp.</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kunming General Hosp. of PLA</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2nd Hosp. of Zhejiang Univ.</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Hosp.</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>September 2014</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</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 of the department of cardiology</investigator_title>
  </responsible_party>
  <keyword>Bivalirudin</keyword>
  <keyword>Acute myocardial infarction</keyword>
  <keyword>percutaneous transluminal coronary angioplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>Tirofiban</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/NCT01696110
org study id: SYNH20120001
secondary id: 2011BAI11B07
nct id: NCT01696110
lead sponsor: 
has dmc: Yes
The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three
      antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or
      unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.

      All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of
      the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical
      research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous
      coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or
      unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa
      inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The
      purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients
      with DES.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Net Adverse Clinical Events
time frame: 30 days
description: A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
measure: Net adverse clinical events
time frame: 1 year
description: a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
measure: any bleedings (BARC class)
time frame: 30 day
description: including all BARC class (class 1-5)
measure: Major adverse cardiac and cerebral events (MACCE)
time frame: 30 days and 1 year
description: a composite of all cause death, reinfarction, target vessel revascularization or stroke
measure: Thrombocytopenia
time frame: 30 days
description: Defined as a decrease of platelet count of more than 50% or more than 150000 platelet/mm3 compared with baseline within 24h after study drug administration
measure: stent thrombosis
time frame: 30 days and 1 year
description: by ARC definition
arm group label: Bivalirudin
arm group type: Experimental
description: Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.
arm group label: Heparin monotherapy
arm group type: Active Comparator
description: 100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.
arm group label: heparin plus tirofiban
arm group type: Active Comparator
description: heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
intervention type: Drug
intervention name: Bivalirudin
description: Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
arm group label: Bivalirudin
other name: Taijianing
intervention type: Drug
intervention name: heparin
description: heparin monotherapy
arm group label: Heparin monotherapy
arm group label: heparin plus tirofiban
intervention type: Drug
intervention name: heparin plus tirofiban
description: combined use of heparin and tirofiban during PCI
arm group label: heparin plus tirofiban
other name: brand name of tirofiban: Xinweining
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yaling Han, MD
role: Principal Investigator
affiliation: Shenyang Northern Hospital,China
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shenyang Northern Hospital
investigator full name: Han Yaling
investigator title: director of the department of cardiology
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Heparin
mesh term: Calcium heparin
mesh term: Tirofiban
mesh term: Bivalirudin