<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/NCT02209909</url>
  </required_header>
  <id_info>
    <org_study_id>OPCAB_ASA_PLT activation</org_study_id>
    <nct_id>NCT02209909</nct_id>
  </id_info>
  <brief_title>Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery</brief_title>
  <official_title>Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus&#xD;
      formation. The purpose of this study is to assess the effects of preoperative continuation of&#xD;
      aspirin on platelet activation after off pump coronary artery bypass surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or&#xD;
      discontinue aspirin before surgery.&#xD;
&#xD;
      Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In&#xD;
      this study, we will compare platelet-activated markers and conventional coagulation tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</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>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in platelet p-selectin at 48 hours after operation</measure>
    <time_frame>after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation</time_frame>
    <description>Primary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation</measure>
    <time_frame>after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation</time_frame>
    <description>prothrombin time (international normalized ratio), activated partial thromboplastin time, fibrinogen</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change from baseline in platelet aggregation at the time of end of operation, 24 hour after operation, and 48hr after operation</measure>
    <time_frame>after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation</time_frame>
    <description>prediction for stratification of bleeding risk due to antiplatelet agent using multiplate</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>aspirin continuation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention : Low-dose aspirin (&lt; 100mg/day) is used before OPCAB surgery in the aspirin continuation group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin discontinuation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin continuation</intervention_name>
    <description>Patients are randomized to continue aspirin before OPCAB surgery.</description>
    <arm_group_label>aspirin continuation</arm_group_label>
    <other_name>Low-dose aspirin (&lt; 100mg/day)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aspirin discontinuation</intervention_name>
    <description>Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.</description>
    <arm_group_label>aspirin discontinuation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age : 20-80&#xD;
&#xD;
          -  elective OPCAB&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coagulation disorder&#xD;
&#xD;
          -  emergency operation, re-operation&#xD;
&#xD;
          -  co-existing valvular disease&#xD;
&#xD;
          -  less than 6 months after cerebral vascular accident&#xD;
&#xD;
          -  heparin induced thrombocytopenia&#xD;
&#xD;
          -  heparin resistance&#xD;
&#xD;
          -  menstrual phase&#xD;
&#xD;
          -  preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic&#xD;
             balloon pump application&#xD;
&#xD;
          -  less than 12 months after myocardiac infarction&#xD;
&#xD;
          -  less than 10 days after unstable angina&#xD;
&#xD;
          -  less than 30 days after percutaneous coronary intervention&#xD;
&#xD;
          -  less than 6 wks after bare metal stent insertion&#xD;
&#xD;
          -  less than 12 months after drug eluting stent insertion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunseok Jeon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 20, 2016</last_update_submitted>
  <last_update_submitted_qc>April 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>preoperative aspirin use</keyword>
  <keyword>platelet activation</keyword>
  <keyword>off pump coronary artery bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</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/NCT02209909
org study id: OPCAB_ASA_PLT activation
nct id: NCT02209909
lead sponsor: 
has dmc: Yes
Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus
      formation. The purpose of this study is to assess the effects of preoperative continuation of
      aspirin on platelet activation after off pump coronary artery bypass surgery.
Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or
      discontinue aspirin before surgery.

      Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In
      this study, we will compare platelet-activated markers and conventional coagulation tests.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Care Provider, Outcomes Assessor)
measure: change from baseline in platelet p-selectin at 48 hours after operation
time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
description: Primary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.
measure: change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation
time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
description: prothrombin time (international normalized ratio), activated partial thromboplastin time, fibrinogen
measure: change from baseline in platelet aggregation at the time of end of operation, 24 hour after operation, and 48hr after operation
time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
description: prediction for stratification of bleeding risk due to antiplatelet agent using multiplate
arm group label: aspirin continuation
arm group type: Experimental
description: Intervention : Low-dose aspirin (< 100mg/day) is used before OPCAB surgery in the aspirin continuation group.
arm group label: aspirin discontinuation
arm group type: Experimental
description: Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.
intervention type: Drug
intervention name: aspirin continuation
description: Patients are randomized to continue aspirin before OPCAB surgery.
arm group label: aspirin continuation
other name: Low-dose aspirin (< 100mg/day)
intervention type: Drug
intervention name: aspirin discontinuation
description: Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.
arm group label: aspirin discontinuation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yunseok Jeon, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Aspirin