<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/NCT01710436</url>
  </required_header>
  <id_info>
    <org_study_id>RDPAC2012</org_study_id>
    <nct_id>NCT01710436</nct_id>
  </id_info>
  <brief_title>Relationship Between Dosage of Clopidogrel and Platelet Aggregation in Chinese With Different Genotype</brief_title>
  <acronym>RDPAC</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, observational study to estimate the relationship between dosage&#xD;
      of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators&#xD;
      suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention&#xD;
      (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in platelet aggregation</measure>
    <time_frame>1 month and 6 months after PCI</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events (MACE); Bleeding events</measure>
    <time_frame>6 months after PCI</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">880</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Low dose - Wild genotype (LW)</arm_group_label>
    <description>75mg Qd &gt; 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 wild genotype</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose - Variant genotype (LV)</arm_group_label>
    <description>75mg Qd &gt; 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 variant genotype</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose - Wild genotype (HW)</arm_group_label>
    <description>300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 wild genotype</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose - Variant genotype (HV)</arm_group_label>
    <description>300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 variant genotype</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese coronary heart disease (CHD) patient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  accept PCI in Chinese CHD patients&#xD;
&#xD;
          -  expected dual antiplatelet therapy (DAPT) at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  another planned PCI within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiovascular Institute and Fu Wai Hospital, CAMS &amp; PUMC</name>
      <address>
        <city>Beijing</city>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>May 16, 2013</last_update_submitted>
  <last_update_submitted_qc>May 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Xiaoxing Zhang</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT01710436
org study id: RDPAC2012
nct id: NCT01710436
lead sponsor: 
has dmc: Yes
This study is a prospective, observational study to estimate the relationship between dosage
      of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators
      suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention
      (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.
observational model: Case-Control
time perspective: Prospective
measure: Change from Baseline in platelet aggregation
time frame: 1 month and 6 months after PCI
measure: Major adverse cardiovascular events (MACE); Bleeding events
time frame: 6 months after PCI
arm group label: Low dose - Wild genotype (LW)
description: 75mg Qd > 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 wild genotype
arm group label: Low dose - Variant genotype (LV)
description: 75mg Qd > 7d Clopidogrel pre-treatment before PCI, according to the reality; CYP2C19 variant genotype
arm group label: High dose - Wild genotype (HW)
description: 300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 wild genotype
arm group label: High dose - Variant genotype (HV)
description: 300mg Clopidogrel loading dose pre-treatment before PCI, according to the reality; CYP2C19 variant genotype
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Xiaoxing Zhang
investigator title: MD
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia