<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/NCT01721590</url>
  </required_header>
  <id_info>
    <org_study_id>SYNH-20120929</org_study_id>
    <nct_id>NCT01721590</nct_id>
  </id_info>
  <brief_title>Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease</brief_title>
  <acronym>Talent</acronym>
  <official_title>Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Han Yaling</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>
      Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent&#xD;
      reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this&#xD;
      prospective randomized study,all patients in control group will receive blank placebo ,all&#xD;
      patients in test group will receive tongxinluo.All patients will be followed up for one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary endpoint is Platelet Reaction Unit( by VerifyNow) at 30 days.The secondary&#xD;
      endpoints include inflammation marker (hsCRP、CD62P-CD41),TT,FIB and PT at 30 days,and&#xD;
      MI、Ischemic Stroke, target vessel revascularization and all-cause mortality 、bleeding events&#xD;
      at 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">May 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet reaction unit(PRU) measured by verifyNow</measure>
    <time_frame>1 month</time_frame>
    <description>to measure the rate of HPR(PRU ≤ 235)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammation Marker (hsCRP、CD62P-CD41)</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma fibrinogen concentration</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin time</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major adverse cardiovascular events</measure>
    <time_frame>1 year</time_frame>
    <description>Including MI,Stroke,target vessel revascularization,and all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bleeding event</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse drug reaction and withdrawal rate</measure>
    <time_frame>1 month ，1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angina recurrence</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Traditional Chinese medicine angina symptoms scores</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-stent thrombosis</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo，3 capsules/time，3times/day for 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tongxinluo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tongxinluo 3 capsules/time 3times/day for 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tongxinluo</intervention_name>
    <description>Tongxinluo,3 capsules/time 3times/day for 1 year</description>
    <arm_group_label>Tongxinluo</arm_group_label>
    <other_name>Tongxinluo capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>3 capsules/time，3times/day for 1 year</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>placebo capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - (1)ACS (including unstable angina pectoris, non-ST-segment elevation myocardial&#xD;
        infarction and ST-elevation myocardial infarction) （2）Accept at least one coronary stent.&#xD;
        （3）The age between18 and 75 . （4）High on-treatment platelet reactivity defined as an&#xD;
        ADP-induced platelet aggregation (by VerifyNow，PRU≥236）at 24 hr after clopidogrel loading&#xD;
        (300 ~ 600mg)or 24 hours after PCI.&#xD;
&#xD;
        （5）Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  （1）Tongxinluo contraindication . （2）Receiving GP IIb / IIIa receptor antagonist&#xD;
             treatment （3）Who complicate the known bleeding tendency and blood system diseases.&#xD;
             （4）NYHA grade III ~ IV （5）Aspirin or clopidogrel allergies （6）Severe liver or kidney&#xD;
             dysfunction （7）Pregnancy （8）Cann't accept 30 days supervision and blood proofer.&#xD;
             （9）Other serious illness, life expectancy less than 6 months. （10) Planned surgery&#xD;
             recently （11) PCI again within 30 days. (12) Mental diseases interfering understanding&#xD;
             the informed consent form （13）Accept other drugs or participate in other clinical&#xD;
             research at the same time .&#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>Yaling Han, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shenyang Northern Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ShenZhou Hopital Of ShenYang Medical College</name>
      <address>
        <city>ShengYang</city>
        <state>Liaoning</state>
        <zip>110032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 463th Hospital Of PLA</name>
      <address>
        <city>ShenYang</city>
        <state>Liaoning</state>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>December 21, 2015</last_update_submitted>
  <last_update_submitted_qc>December 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shenyang Northern Hospital</investigator_affiliation>
    <investigator_full_name>Han Yaling</investigator_full_name>
    <investigator_title>vice president</investigator_title>
  </responsible_party>
  <keyword>high on-treatment platelet reactivity</keyword>
  <keyword>Coronary Heart Disease</keyword>
  <keyword>Tongxinluo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_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/NCT01721590
org study id: SYNH-20120929
nct id: NCT01721590
lead sponsor: 
has dmc: Yes
Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent
      reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this
      prospective randomized study,all patients in control group will receive blank placebo ,all
      patients in test group will receive tongxinluo.All patients will be followed up for one year.
The primary endpoint is Platelet Reaction Unit( by VerifyNow) at 30 days.The secondary
      endpoints include inflammation marker (hsCRP、CD62P-CD41),TT,FIB and PT at 30 days,and
      MI、Ischemic Stroke, target vessel revascularization and all-cause mortality 、bleeding events
      at 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Platelet reaction unit(PRU) measured by verifyNow
time frame: 1 month
description: to measure the rate of HPR(PRU ≤ 235)
measure: Inflammation Marker (hsCRP、CD62P-CD41)
time frame: 1 month
measure: Plasma fibrinogen concentration
time frame: 1 month
measure: Thrombin time
time frame: 1 month
measure: Prothrombin time
time frame: 1 month
measure: major adverse cardiovascular events
time frame: 1 year
description: Including MI,Stroke,target vessel revascularization,and all-cause mortality
measure: bleeding event
time frame: 1 year
measure: Adverse drug reaction and withdrawal rate
time frame: 1 month ，1 year
measure: Angina recurrence
time frame: 1 year
measure: Traditional Chinese medicine angina symptoms scores
time frame: 1 year
measure: Intra-stent thrombosis
time frame: 1 year
arm group label: Control
arm group type: Placebo Comparator
description: Placebo，3 capsules/time，3times/day for 1 year
arm group label: Tongxinluo
arm group type: Experimental
description: Tongxinluo 3 capsules/time 3times/day for 1 year
intervention type: Drug
intervention name: Tongxinluo
description: Tongxinluo,3 capsules/time 3times/day for 1 year
arm group label: Tongxinluo
other name: Tongxinluo capsule
intervention type: Drug
intervention name: placebo
description: 3 capsules/time，3times/day for 1 year
arm group label: Control
other name: placebo capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yaling Han, Dr
role: Principal Investigator
affiliation: Shenyang Northern Hospital
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shenyang Northern Hospital
investigator full name: Han Yaling
investigator title: vice president
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Heart Diseases