<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/NCT04431349</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-MDB-19-434</org_study_id>
    <nct_id>NCT04431349</nct_id>
  </id_info>
  <brief_title>Comparison of CABG Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel</brief_title>
  <acronym>CABG</acronym>
  <official_title>Comparison of Coronary Artery Bypass Graft Surgery Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and&#xD;
      a P2Y12-receptor antagonist) is a commonly used method because of its excellent&#xD;
      antithrombotic effect. In particular, in patients with acute myocardial infarction, who&#xD;
      receive coronary angiography as an emergency, the dual antiplatelet is used immediately&#xD;
      before the test to prevent and test further clot formation, regardless of whether or not the&#xD;
      patient had previously taken dual antiplatelet.&#xD;
&#xD;
      Ticagrelor, a direct-acting and reversible ADP receptor antagonist, was introduced in Denmark&#xD;
      in 2013 and is now the most commonly used ADP receptor antagonist in the treatment of ACS.&#xD;
      Compared to its predecessor clopidogrel, the pharmacokinetic proﬁl of ticagrelor is more&#xD;
      predictable, demonstrating a faster onset of action and a more consistent platelet&#xD;
      inhibition. However, because of the excellent antithrombotic effect and increased bleeding&#xD;
      potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected&#xD;
      with a high probability, and in case of fatal surgery, the drug should be discontinued for 5&#xD;
      days.&#xD;
&#xD;
      Most patients who receive emergency coronary heart surgery after undergoing coronary&#xD;
      angiography as an emergency due to an acute myocardial infarction, it take approximately&#xD;
      24-48 hours to undergo surgery after examination. In fact, there have been reports of&#xD;
      large-scale cross-country studies that do not increase bleeding risk compared to 5 days until&#xD;
      3 days after ticagrelor is stopped. Therefore, this study aimed to retrospectively analyze&#xD;
      the bleeding tendency by analyzing the records of patients using clopidogrel or ticagrelor in&#xD;
      preoperative coronary angiography for patients undergoing emergency CABG surgery from 2016 to&#xD;
      September 2019.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">May 6, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major bleeding event</measure>
    <time_frame>within 48hours after operation</time_frame>
    <description>major bleeding defined as BARC-CABG related bleeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RBC transfusion amount</measure>
    <time_frame>through study completion, an average of 1 month</time_frame>
    <description>total amount of RBC transfusion within hospital stay after operation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1097</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <condition>Ticagrelor</condition>
  <condition>Clopidogrel</condition>
  <arm_group>
    <arm_group_label>ticagrelor</arm_group_label>
    <description>The patient with acute myocardial infarction received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clopidogrel</arm_group_label>
    <description>The patient with acute myocardial infarction received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ticagrelor 180mg</intervention_name>
    <description>Patient received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.</description>
    <arm_group_label>ticagrelor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel 75mg</intervention_name>
    <description>Patient received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.</description>
    <arm_group_label>clopidogrel</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Emergency OPCAB or CABG surgery in Ajou university hospital from January 2016 to September&#xD;
        2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient with acute myocardial infarction received loading dose of clopidogrel or&#xD;
             ticagrelor for coronary angiography within 2 days prior to emergency OPCAB or CABG.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart surgery combined with other operation (valve surgery, aorta surgery, trauma&#xD;
             surgery)&#xD;
&#xD;
          -  History of coagulopathy&#xD;
&#xD;
          -  History of liver cirrhosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jiyoung Yoo</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blood Loss, Surgical</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Ticagrelor</mesh_term>
  </intervention_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/NCT04431349
org study id: AJIRB-MED-MDB-19-434
nct id: NCT04431349
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and
      a P2Y12-receptor antagonist) is a commonly used method because of its excellent
      antithrombotic effect. In particular, in patients with acute myocardial infarction, who
      receive coronary angiography as an emergency, the dual antiplatelet is used immediately
      before the test to prevent and test further clot formation, regardless of whether or not the
      patient had previously taken dual antiplatelet.

      Ticagrelor, a direct-acting and reversible ADP receptor antagonist, was introduced in Denmark
      in 2013 and is now the most commonly used ADP receptor antagonist in the treatment of ACS.
      Compared to its predecessor clopidogrel, the pharmacokinetic proﬁl of ticagrelor is more
      predictable, demonstrating a faster onset of action and a more consistent platelet
      inhibition. However, because of the excellent antithrombotic effect and increased bleeding
      potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected
      with a high probability, and in case of fatal surgery, the drug should be discontinued for 5
      days.

      Most patients who receive emergency coronary heart surgery after undergoing coronary
      angiography as an emergency due to an acute myocardial infarction, it take approximately
      24-48 hours to undergo surgery after examination. In fact, there have been reports of
      large-scale cross-country studies that do not increase bleeding risk compared to 5 days until
      3 days after ticagrelor is stopped. Therefore, this study aimed to retrospectively analyze
      the bleeding tendency by analyzing the records of patients using clopidogrel or ticagrelor in
      preoperative coronary angiography for patients undergoing emergency CABG surgery from 2016 to
      September 2019.
observational model: Cohort
time perspective: Retrospective
measure: Major bleeding event
time frame: within 48hours after operation
description: major bleeding defined as BARC-CABG related bleeding
measure: RBC transfusion amount
time frame: through study completion, an average of 1 month
description: total amount of RBC transfusion within hospital stay after operation
arm group label: ticagrelor
description: The patient with acute myocardial infarction received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.
arm group label: clopidogrel
description: The patient with acute myocardial infarction received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.
intervention type: Drug
intervention name: Ticagrelor 180mg
description: Patient received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.
arm group label: ticagrelor
intervention type: Drug
intervention name: Clopidogrel 75mg
description: Patient received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.
arm group label: clopidogrel
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Jiyoung Yoo
investigator title: Assistant professor
mesh term: Blood Loss, Surgical
mesh term: Clopidogrel
mesh term: Ticagrelor
sharing ipd: No