<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/NCT03792035</url>
  </required_header>
  <id_info>
    <org_study_id>SP-YFC-03-CTS-AMI</org_study_id>
    <secondary_id>2017YFC1700503</secondary_id>
    <nct_id>NCT03792035</nct_id>
  </id_info>
  <brief_title>China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction</brief_title>
  <official_title>China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China National Center for Cardiovascular Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China National Center for Cardiovascular Diseases</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>
      To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the&#xD;
      treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical&#xD;
      efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse&#xD;
      cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial&#xD;
      re-infarction, emergency coronary revascularization and cerebral stroke), severe&#xD;
      complications (including cardiogenic shock, heart failure, mechanical complications and&#xD;
      malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and&#xD;
      safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due&#xD;
      to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as&#xD;
      all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence&#xD;
      of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and&#xD;
      improving left ventricular systolic function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 23, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACCE</measure>
    <time_frame>30-day</time_frame>
    <description>30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Revascularization</measure>
    <time_frame>30-day</time_frame>
    <description>Incidence of revascularization of the primary endpoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral stroke</measure>
    <time_frame>30-day</time_frame>
    <description>Incidence of cerebral stroke of the primary endpoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STEMI</measure>
    <time_frame>30-day</time_frame>
    <description>30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V</measure>
    <time_frame>30-day</time_frame>
    <description>The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V at 30-day between 0-30%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACCE</measure>
    <time_frame>1 year</time_frame>
    <description>1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent restenosis</measure>
    <time_frame>1 year</time_frame>
    <description>1-year incidence of In-stent restenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality rate at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial reperfusion and no-reflow</measure>
    <time_frame>2 hours, 24 hours and 7 days</time_frame>
    <description>Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total white cell count</measure>
    <time_frame>7 days, 1 month, 6 months and 1 year after medication</time_frame>
    <description>Normal value: 4-10, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.</description>
  </other_outcome>
  <other_outcome>
    <measure>Red blood cell</measure>
    <time_frame>7 days, 1 month, 6 months and 1 year after medication</time_frame>
    <description>Normal value: 3.5-5, unit: 1012/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>7 days, 1 month, 6 months and 1 year after medication</time_frame>
    <description>Normal value: 110-150, unit: g/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood platelet count</measure>
    <time_frame>7 days, 1 month, 6 months and 1 year after medication</time_frame>
    <description>Normal value: 100-300, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3796</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tongxinluo</intervention_name>
    <description>tid, po.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>tid, po.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&gt;18 years;&#xD;
&#xD;
          2. Within 24 hours of infarctional chest pain onset;&#xD;
&#xD;
          3. ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left&#xD;
             bundle branch block (LBBB);&#xD;
&#xD;
          4. Voluntary participation in the study with consent forms signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Critically illness due to STEMI;&#xD;
&#xD;
          2. Long-term (&gt;20 min) cardio-pulmonary resuscitation (CPR);&#xD;
&#xD;
          3. Suspected aortic dissection or acute pulmonary embolism;&#xD;
&#xD;
          4. Explicit mechanical complications, including interventricular septum perforation,&#xD;
             rupture of papillary muscles and chordae tendineae, or on-going or ruptured left&#xD;
             ventricular free walls.&#xD;
&#xD;
          5. Serious cardiogenic shock and do not responding to hypertensive agents;&#xD;
&#xD;
          6. Uncontrolled acute left heart failure or pulmonary edema;&#xD;
&#xD;
          7. Malignant arrhythmias uncontrolled by anti-arrhythmia agents;&#xD;
&#xD;
          8. Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract,&#xD;
             urinary tract or other organs within 1 month;&#xD;
&#xD;
          9. Presence of active hemorrhage at any part of the body (including menstruation);&#xD;
&#xD;
         10. Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders;&#xD;
&#xD;
         11. Current usage of anticoagulants (such as Warfarin or new anticoagulants);&#xD;
&#xD;
         12. . Serious hepatorenal dysfunction [ATL≥5 ULN (upper limit of normal), Cr&gt;134μmol/L&#xD;
             (2mg%) or eGFR&lt;45ml/min/1.73m2];&#xD;
&#xD;
         13. Serious chronic obstructive pulmonary disease (COPD) or respiratory failure;&#xD;
&#xD;
         14. . Severe infection:&#xD;
&#xD;
         15. . Very weak or frailty;&#xD;
&#xD;
         16. . Neuropsychiatric system diseases;&#xD;
&#xD;
         17. . Malignancies;&#xD;
&#xD;
         18. . Other pathophysiological conditions with expected survival time &lt;1 year;&#xD;
&#xD;
         19. Allergy to the ingredients of this investigational drug;&#xD;
&#xD;
         20. Women who are in pregnancy or nursery;&#xD;
&#xD;
         21. Participation in clinical study of other traditional Chinese medicine (TCM);&#xD;
&#xD;
         22. Unsuitability to participate in this study due to other diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yue-Jin Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiang-Dong Li, MD</last_name>
    <phone>13263138665</phone>
    <email>fuwai_lxd@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangdong Li, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Aerospace General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100076</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dong-Nan Hu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Renhe Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102600</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jixiang Ge, Dean</last_name>
      <phone>13716826088</phone>
      <email>ge-jx2004@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Harrison International Peace Hospital</name>
      <address>
        <city>Hengshui</city>
        <state>Hebei</state>
        <zip>053000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Qun Zheng, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Provincial Peoples Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chuan-Yu Gao, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taian City Central Hospital</name>
      <address>
        <city>Tai'an</city>
        <state>Shandong</state>
        <zip>271000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Huan-Yi Zhang, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Teaching Hospital of Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300193</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jing-Yuan Mao, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 30, 2019</last_update_submitted>
  <last_update_submitted_qc>July 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
    <investigator_full_name>fuwaihospital</investigator_full_name>
    <investigator_title>Assistant dean</investigator_title>
  </responsible_party>
  <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>
  <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/NCT03792035
org study id: SP-YFC-03-CTS-AMI
secondary id: 2017YFC1700503
nct id: NCT03792035
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the
      treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical
      efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse
      cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial
      re-infarction, emergency coronary revascularization and cerebral stroke), severe
      complications (including cardiogenic shock, heart failure, mechanical complications and
      malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and
      safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due
      to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as
      all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence
      of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and
      improving left ventricular systolic function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: MACCE
time frame: 30-day
description: 30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)
measure: Revascularization
time frame: 30-day
description: Incidence of revascularization of the primary endpoints
measure: Cerebral stroke
time frame: 30-day
description: Incidence of cerebral stroke of the primary endpoints
measure: STEMI
time frame: 30-day
description: 30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.
measure: The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V
time frame: 30-day
description: The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V at 30-day between 0-30%.
measure: MACCE
time frame: 1 year
description: 1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event.
measure: In-stent restenosis
time frame: 1 year
description: 1-year incidence of In-stent restenosis
measure: All-cause mortality rate at 1 year
time frame: 1 year
description: Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.
measure: Myocardial reperfusion and no-reflow
time frame: 2 hours, 24 hours and 7 days
description: Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy.
measure: Total white cell count
time frame: 7 days, 1 month, 6 months and 1 year after medication
description: Normal value: 4-10, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
measure: Red blood cell
time frame: 7 days, 1 month, 6 months and 1 year after medication
description: Normal value: 3.5-5, unit: 1012/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
measure: Hemoglobin
time frame: 7 days, 1 month, 6 months and 1 year after medication
description: Normal value: 110-150, unit: g/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
measure: Blood platelet count
time frame: 7 days, 1 month, 6 months and 1 year after medication
description: Normal value: 100-300, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.
arm group label: Experimental group
arm group type: Experimental
description: First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
arm group label: Control group
arm group type: Placebo Comparator
description: First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
intervention type: Drug
intervention name: Tongxinluo
description: tid, po.
arm group label: Experimental group
intervention type: Drug
intervention name: Placebos
description: tid, po.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yue-Jin Yang, MD
role: Principal Investigator
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
last name: Xiang-Dong Li, MD
phone: 13263138665
email: fuwai_lxd@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China National Center for Cardiovascular Diseases
investigator full name: fuwaihospital
investigator title: Assistant dean
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No