<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/NCT02184884</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0172</org_study_id>
    <nct_id>NCT02184884</nct_id>
  </id_info>
  <brief_title>Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength,&#xD;
      maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in&#xD;
      platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A&#xD;
      study reported that the TEG® can be used as routine monitoring of the variability in ADP&#xD;
      receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay,&#xD;
      we could find out the perioperative clopidogrel responsiveness of the patients with ACS&#xD;
      undergoing OPCAB.&#xD;
&#xD;
      The purpose of this study is to determine whether the rate of the major adverse cardiac&#xD;
      events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in&#xD;
      the patients with high degree of clopidogrel resistance, who are scheduled to undergo the&#xD;
      OPCAB due to ACS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Rate of the major adverse cardiac events</measure>
    <time_frame>at 30 days after surgery</time_frame>
    <description>major adverse cardiac events(MACE) includes the MI, revascularization and cardiac death. Rate of the MACE will be higher in the patients with high degree of clopidogrel resistance.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">195</enrollment>
  <condition>Acute Coronary Syndrome (ACS)</condition>
  <arm_group>
    <arm_group_label>MACE group</arm_group_label>
    <description>the patients with MACE after OPCAB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no MACE group</arm_group_label>
    <description>the patients without MACE after OPCAB</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MACE after OPCAB</intervention_name>
    <arm_group_label>MACE group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>without MACE after OPCAB</intervention_name>
    <arm_group_label>no MACE group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with acute coronary syndrome (ACS) undergoing off-pump coronary artery bypass&#xD;
        surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. the patients with ACS undergoing OPCAB&#xD;
&#xD;
          2. the patients over 20 years of age&#xD;
&#xD;
          3. the patient who have been taking [100 mg of Aspirin] and [75 mg of clopidogrel or 180&#xD;
             mg of ticagrelor] for more than one week and who continue within 3 to 5 days prior to&#xD;
             surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. re-operation or emergency operation&#xD;
&#xD;
          2. the patients with bleeding tendency of decreased liver function&#xD;
&#xD;
          3. Left ventricular ejection fraction &lt; 40% by echo&#xD;
&#xD;
          4. preoperative hematocrit &lt; 33% or platelet count &lt; 100,000/mm3 or creatinine &gt; 1.4&#xD;
             mg/dL&#xD;
&#xD;
          5. abnormal preoperative prothrombin time or activated partial thromboplastin time&#xD;
&#xD;
          6. preoperative use of other PO antiplatelet drugs or PO anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02184884
org study id: 4-2014-0172
nct id: NCT02184884
lead sponsor: 
has dmc: No
The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength,
      maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in
      platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A
      study reported that the TEG® can be used as routine monitoring of the variability in ADP
      receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay,
      we could find out the perioperative clopidogrel responsiveness of the patients with ACS
      undergoing OPCAB.

      The purpose of this study is to determine whether the rate of the major adverse cardiac
      events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in
      the patients with high degree of clopidogrel resistance, who are scheduled to undergo the
      OPCAB due to ACS.
observational model: Case-Control
time perspective: Prospective
measure: Rate of the major adverse cardiac events
time frame: at 30 days after surgery
description: major adverse cardiac events(MACE) includes the MI, revascularization and cardiac death. Rate of the MACE will be higher in the patients with high degree of clopidogrel resistance.
arm group label: MACE group
description: the patients with MACE after OPCAB
arm group label: no MACE group
description: the patients without MACE after OPCAB
intervention type: Device
intervention name: MACE after OPCAB
arm group label: MACE group
intervention type: Device
intervention name: without MACE after OPCAB
arm group label: no MACE group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome