<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/NCT04407312</url>
  </required_header>
  <id_info>
    <org_study_id>GNUHIRB 2012-01-005</org_study_id>
    <nct_id>NCT04407312</nct_id>
  </id_info>
  <brief_title>Cilostazol and Endothelial Progenitor Cell</brief_title>
  <acronym>EPISODE</acronym>
  <official_title>Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients With Acute Myocardial Infarction: A Randomized, Placebo-controlled ACCEL-EPISODE Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gyeongsang National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Gyeongsang National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess impact of adjunctive cilostazol on endothelial progenitor cell (EPC) mobilization&#xD;
      in patients with acute myocardial infarction (To reveal the role of cilostazol in&#xD;
      up-regulation of EPC count)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary endpoint: % Change of EPC count&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
        1. Changes of ADP/AA/collagen-induced PFT&#xD;
&#xD;
        2. Changes of lipid profile and high sensitivity-C-reactive protein&#xD;
&#xD;
        3. Change of TEG measurements&#xD;
&#xD;
        4. Change of PWV&#xD;
&#xD;
        5. Predictors of EPC count (baseline and 1-month)&#xD;
&#xD;
        6. ischemic (CV death, MI &amp; stroke) and bleeding events (BARC)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline CD133+/KDR+ at 30 days</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>Peripheral blood mononuclear cells measurement by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline CD34+/KDR+ at 30 days</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>Peripheral blood mononuclear cells measurement by flow cytometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of Platelet inhibition</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>Platelet function test by VerifyNow assay at 30-day follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>the correlation between the changes of EPC subsets and ∆Platelet reactivity unit (PRU) by Pearson's method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>the correlation between the changes of EPC subsets and ∆PRU by Pearson's method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bleeding events by BACR definition</measure>
    <time_frame>30 days</time_frame>
    <description>Safety outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Myocardial Infarction, Acute</condition>
  <arm_group>
    <arm_group_label>CILO group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention:&#xD;
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.&#xD;
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.&#xD;
For the CILO group, cilostazol-SR 200 mg daily was added to dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).&#xD;
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.&#xD;
Drug:&#xD;
Cilostazol-SR, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention:&#xD;
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.&#xD;
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.&#xD;
In the Placebo group, placebo tablet was administered on top of dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).&#xD;
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.&#xD;
Drug:&#xD;
Placebo, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cilostazol Tablets</intervention_name>
    <description>Cilostazol-SR, capsule, 200mg, once daily, 30 days.</description>
    <arm_group_label>CILO group</arm_group_label>
    <other_name>Cilostazol-SR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo, tablet, 200mg, once daily, 30 days.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Astrix, capsule,100mg, once daily, 30 days.</description>
    <arm_group_label>CILO group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Astrix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <description>Plavix, tablet, 75mg, once daily, 30 days.</description>
    <arm_group_label>CILO group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Plavix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  naïve AMI&#xD;
&#xD;
          -  undergoing successful coronary stent implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  high-risk patients for thrombotic event;&#xD;
&#xD;
          -  a history of active bleeding or bleeding diatheses;&#xD;
&#xD;
          -  contraindication to antiplatelet therapy;&#xD;
&#xD;
          -  hemodynamic or electrical instability;&#xD;
&#xD;
          -  oral anticoagulation therapy;&#xD;
&#xD;
          -  left ventricular ejection fraction &lt; 30%;&#xD;
&#xD;
          -  leukocyte count &lt; 3,000/mm3 and/or platelet count &lt; 100,000/mm3;&#xD;
&#xD;
          -  AST or ALT &gt; 3 times the respective the upper limit;&#xD;
&#xD;
          -  serum creatinine level &gt; 3.5 mg/dL;&#xD;
&#xD;
          -  stroke within 3 months;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  non-cardiac disease with a life expectancy &lt; 1 year;&#xD;
&#xD;
          -  any patients not tolerable or suitable for coronary intervention; and&#xD;
&#xD;
          -  inability to follow the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-Hoon Jeong, MD,.PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gyeongsang National University Changwon Hospital</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gyeongsang National University Hospital</investigator_affiliation>
    <investigator_full_name>Yongwhi Park, MD, PhD.</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Endothelial progenitor cell</keyword>
  <keyword>Myocardial infarction, acute</keyword>
  <keyword>Platelets</keyword>
  <keyword>Cilostazol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Cilostazol</mesh_term>
    <mesh_term>Clopidogrel</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/NCT04407312
org study id: GNUHIRB 2012-01-005
nct id: NCT04407312
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess impact of adjunctive cilostazol on endothelial progenitor cell (EPC) mobilization
      in patients with acute myocardial infarction (To reveal the role of cilostazol in
      up-regulation of EPC count)
Primary endpoint: % Change of EPC count

      Secondary endpoints:

        1. Changes of ADP/AA/collagen-induced PFT

        2. Changes of lipid profile and high sensitivity-C-reactive protein

        3. Change of TEG measurements

        4. Change of PWV

        5. Predictors of EPC count (baseline and 1-month)

        6. ischemic (CV death, MI & stroke) and bleeding events (BARC)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes from baseline CD133+/KDR+ at 30 days
time frame: baseline and 30 days
description: Peripheral blood mononuclear cells measurement by flow cytometry
measure: Changes from baseline CD34+/KDR+ at 30 days
time frame: baseline and 30 days
description: Peripheral blood mononuclear cells measurement by flow cytometry
measure: Levels of Platelet inhibition
time frame: baseline and 30 days
description: Platelet function test by VerifyNow assay at 30-day follow-up
measure: Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method
time frame: baseline and 30 days
description: the correlation between the changes of EPC subsets and ∆Platelet reactivity unit (PRU) by Pearson's method
measure: Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow
time frame: baseline and 30 days
description: the correlation between the changes of EPC subsets and ∆PRU by Pearson's method
measure: Incidence of bleeding events by BACR definition
time frame: 30 days
description: Safety outcome
arm group label: CILO group
arm group type: Experimental
description: Intervention:
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.
For the CILO group, cilostazol-SR 200 mg daily was added to dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.
Drug:
Cilostazol-SR, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Intervention:
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.
In the Placebo group, placebo tablet was administered on top of dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.
Drug:
Placebo, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.
intervention type: Drug
intervention name: Cilostazol Tablets
description: Cilostazol-SR, capsule, 200mg, once daily, 30 days.
arm group label: CILO group
other name: Cilostazol-SR
intervention type: Drug
intervention name: placebo
description: Placebo, tablet, 200mg, once daily, 30 days.
arm group label: Placebo group
intervention type: Drug
intervention name: Aspirin
description: Astrix, capsule,100mg, once daily, 30 days.
arm group label: CILO group
arm group label: Placebo group
other name: Astrix
intervention type: Drug
intervention name: Clopidogrel
description: Plavix, tablet, 75mg, once daily, 30 days.
arm group label: CILO group
arm group label: Placebo group
other name: Plavix
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Young-Hoon Jeong, MD,.PhD
role: Principal Investigator
affiliation: Gyeongsang National University Changwon Hospital
responsible party type: Principal Investigator
investigator affiliation: Gyeongsang National University Hospital
investigator full name: Yongwhi Park, MD, PhD.
investigator title: Principal investigator
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Aspirin
mesh term: Cilostazol
mesh term: Clopidogrel
sharing ipd: No