<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/NCT03006835</url>
  </required_header>
  <id_info>
    <org_study_id>ky20162060-2</org_study_id>
    <nct_id>NCT03006835</nct_id>
  </id_info>
  <brief_title>Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shenzhen Salubris Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <brief_summary>
    <textblock>
      This is a single-center, randomized, single-blind, investigator-initiated, pharmacological&#xD;
      study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary&#xD;
      intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following&#xD;
      treatment groups:&#xD;
&#xD;
      Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.&#xD;
&#xD;
      Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.&#xD;
&#xD;
      Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.&#xD;
&#xD;
      Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.&#xD;
&#xD;
      Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the&#xD;
      loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram.&#xD;
      Documentation of major adverse cardiac events (death, myocardial infarction, stroke,&#xD;
      revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other&#xD;
      adverse events)will be performed until Day 30.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADP- induced platelet inhibition rate</measure>
    <time_frame>2 hours after the loading dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ADP- induced platelet inhibition rate</measure>
    <time_frame>6 hours after the loading dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ADP- induced platelet inhibition rate</measure>
    <time_frame>30 days after the loading dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>R value (min)</measure>
    <time_frame>2 hours after the loading dose</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Domestic Clopidogrel 300mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Domestic Clopidogrel 300mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Domestic Clopidogrel 600mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Domestic Clopidogrel 600mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imported Clopidogrel 300mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Imported Clopidogrel 300mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imported Clopidogrel 600mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Imported Clopidogrel 600mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <arm_group_label>Domestic Clopidogrel 300mg</arm_group_label>
    <arm_group_label>Domestic Clopidogrel 600mg</arm_group_label>
    <arm_group_label>Imported Clopidogrel 300mg</arm_group_label>
    <arm_group_label>Imported Clopidogrel 600mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient is scheduled to undergo non-urgent PCI&#xD;
&#xD;
          2. The patient is between 18 and 75 years of age (inclusive) and willing to comply with&#xD;
             the protocol&#xD;
&#xD;
          3. The patient or legally acceptable representative is able to read and give written&#xD;
             informed consent and has signed an informed consent form approved by the&#xD;
             Investigator's IRB/IEC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Estimated or measured weight &lt; 55 kg&#xD;
&#xD;
          2. Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation&#xD;
             myocardial infarction (STEMI) within 7 days prior to PCI&#xD;
&#xD;
          3. Uncontrolled hypertension at the time of initial study drug administration defined as&#xD;
             measured systolic blood pressure &gt; 190 mm Hg or diastolic blood pressure &gt; 108 mm Hg&#xD;
&#xD;
          4. Patient has received a clopidogrel loading dose (≥300 mg) within 30 days prior to&#xD;
             randomization; patients on maintenance clopidogrel may be enrolled&#xD;
&#xD;
          5. Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g.,&#xD;
             warfarin) within the 7 days prior to PCI&#xD;
&#xD;
          6. Estimated creatinine clearance (e.g. Cockcroft-Gault) &lt; 45 mL/min&#xD;
&#xD;
          7. Anemia with hemoglobin level &lt; 10 g/dL&#xD;
&#xD;
          8. Thrombocytopenia (platelet count &lt; 100,000/mm3)&#xD;
&#xD;
          9. ALT and/or AST &gt; 2.5 x the ULN or other indication of clinically significant hepatic&#xD;
             dysfunction&#xD;
&#xD;
         10. Facial or head trauma within the last 30 days&#xD;
&#xD;
         11. Intraocular hemorrhage within the last 30 days&#xD;
&#xD;
         12. Gastrointestinal bleeding within the last 30 days&#xD;
&#xD;
         13. Active bleeding, or history of a bleeding disorder or known intracranial vascular&#xD;
             malformation&#xD;
&#xD;
         14. Known allergy or contraindication to aspirin, heparin, clopidogrel, or to any contrast&#xD;
             media&#xD;
&#xD;
         15. Participation in any investigational drug study within 30 days prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ruining zhang, doctor</last_name>
    <role>Study Director</role>
    <affiliation>Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>yi liu, doctor</last_name>
    <phone>86-029-84775183</phone>
    <email>1391643423@qq.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clopidogrel; Platelet Inhibition Ratio</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</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/NCT03006835
org study id: ky20162060-2
nct id: NCT03006835
lead sponsor: 
collaborator: 
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological
      study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary
      intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following
      treatment groups:

      Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.

      Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.

      Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.

      Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.

      Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the
      loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram.
      Documentation of major adverse cardiac events (death, myocardial infarction, stroke,
      revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other
      adverse events)will be performed until Day 30.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: ADP- induced platelet inhibition rate
time frame: 2 hours after the loading dose
measure: ADP- induced platelet inhibition rate
time frame: 6 hours after the loading dose
measure: ADP- induced platelet inhibition rate
time frame: 30 days after the loading dose
measure: R value (min)
time frame: 2 hours after the loading dose
arm group label: Domestic Clopidogrel 300mg
arm group type: Experimental
description: Domestic Clopidogrel 300mg
arm group label: Domestic Clopidogrel 600mg
arm group type: Experimental
description: Domestic Clopidogrel 600mg
arm group label: Imported Clopidogrel 300mg
arm group type: Experimental
description: Imported Clopidogrel 300mg
arm group label: Imported Clopidogrel 600mg
arm group type: Active Comparator
description: Imported Clopidogrel 600mg
intervention type: Drug
intervention name: Clopidogrel
arm group label: Domestic Clopidogrel 300mg
arm group label: Domestic Clopidogrel 600mg
arm group label: Imported Clopidogrel 300mg
arm group label: Imported Clopidogrel 600mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: ruining zhang, doctor
role: Study Director
affiliation: Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China
last name: yi liu, doctor
phone: 86-029-84775183
email: 1391643423@qq.com
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Clopidogrel