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Cilostazol and Endothelial Progenitor Cell (EPISODE)

Primary Purpose

Myocardial Infarction, Acute

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cilostazol Tablets
placebo
Aspirin
Clopidogrel
Sponsored by
Gyeongsang National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction, Acute focused on measuring Endothelial progenitor cell, Myocardial infarction, acute, Platelets, Cilostazol

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • naïve AMI
  • undergoing successful coronary stent implantation

Exclusion Criteria:

  • high-risk patients for thrombotic event;
  • a history of active bleeding or bleeding diatheses;
  • contraindication to antiplatelet therapy;
  • hemodynamic or electrical instability;
  • oral anticoagulation therapy;
  • left ventricular ejection fraction < 30%;
  • leukocyte count < 3,000/mm3 and/or platelet count < 100,000/mm3;
  • AST or ALT > 3 times the respective the upper limit;
  • serum creatinine level > 3.5 mg/dL;
  • stroke within 3 months;
  • pregnancy;
  • non-cardiac disease with a life expectancy < 1 year;
  • any patients not tolerable or suitable for coronary intervention; and
  • inability to follow the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CILO group

    Placebo group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes from baseline CD133+/KDR+ at 30 days
    Peripheral blood mononuclear cells measurement by flow cytometry
    Changes from baseline CD34+/KDR+ at 30 days
    Peripheral blood mononuclear cells measurement by flow cytometry

    Secondary Outcome Measures

    Levels of Platelet inhibition
    Platelet function test by VerifyNow assay at 30-day follow-up
    Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method
    the correlation between the changes of EPC subsets and ∆Platelet reactivity unit (PRU) by Pearson's method
    Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow
    the correlation between the changes of EPC subsets and ∆PRU by Pearson's method
    Incidence of bleeding events by BACR definition
    Safety outcome

    Full Information

    First Posted
    May 20, 2020
    Last Updated
    May 27, 2020
    Sponsor
    Gyeongsang National University Hospital
    Collaborators
    Korea Otsuka Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04407312
    Brief Title
    Cilostazol and Endothelial Progenitor Cell
    Acronym
    EPISODE
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2018 (Actual)
    Study Completion Date
    July 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gyeongsang National University Hospital
    Collaborators
    Korea Otsuka Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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)
    Detailed Description
    Primary endpoint: % Change of EPC count Secondary endpoints: Changes of ADP/AA/collagen-induced PFT Changes of lipid profile and high sensitivity-C-reactive protein Change of TEG measurements Change of PWV Predictors of EPC count (baseline and 1-month) ischemic (CV death, MI & stroke) and bleeding events (BARC)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction, Acute
    Keywords
    Endothelial progenitor cell, Myocardial infarction, acute, Platelets, Cilostazol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CILO group
    Arm Type
    Experimental
    Arm 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 Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm 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(s)
    Cilostazol Tablets
    Other Intervention Name(s)
    Cilostazol-SR
    Intervention Description
    Cilostazol-SR, capsule, 200mg, once daily, 30 days.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Placebo, tablet, 200mg, once daily, 30 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Other Intervention Name(s)
    Astrix
    Intervention Description
    Astrix, capsule,100mg, once daily, 30 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel
    Other Intervention Name(s)
    Plavix
    Intervention Description
    Plavix, tablet, 75mg, once daily, 30 days.
    Primary Outcome Measure Information:
    Title
    Changes from baseline CD133+/KDR+ at 30 days
    Description
    Peripheral blood mononuclear cells measurement by flow cytometry
    Time Frame
    baseline and 30 days
    Title
    Changes from baseline CD34+/KDR+ at 30 days
    Description
    Peripheral blood mononuclear cells measurement by flow cytometry
    Time Frame
    baseline and 30 days
    Secondary Outcome Measure Information:
    Title
    Levels of Platelet inhibition
    Description
    Platelet function test by VerifyNow assay at 30-day follow-up
    Time Frame
    baseline and 30 days
    Title
    Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method
    Description
    the correlation between the changes of EPC subsets and ∆Platelet reactivity unit (PRU) by Pearson's method
    Time Frame
    baseline and 30 days
    Title
    Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow
    Description
    the correlation between the changes of EPC subsets and ∆PRU by Pearson's method
    Time Frame
    baseline and 30 days
    Title
    Incidence of bleeding events by BACR definition
    Description
    Safety outcome
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: naïve AMI undergoing successful coronary stent implantation Exclusion Criteria: high-risk patients for thrombotic event; a history of active bleeding or bleeding diatheses; contraindication to antiplatelet therapy; hemodynamic or electrical instability; oral anticoagulation therapy; left ventricular ejection fraction < 30%; leukocyte count < 3,000/mm3 and/or platelet count < 100,000/mm3; AST or ALT > 3 times the respective the upper limit; serum creatinine level > 3.5 mg/dL; stroke within 3 months; pregnancy; non-cardiac disease with a life expectancy < 1 year; any patients not tolerable or suitable for coronary intervention; and inability to follow the protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Young-Hoon Jeong, MD,.PhD
    Organizational Affiliation
    Gyeongsang National University Changwon Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32492942
    Citation
    Park Y, Kim JH, Kim TH, Koh JS, Hwang SJ, Hwang JY, Jeong YH. Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients with Acute Myocardial Infarction: A Randomized, Placebo-Controlled EPISODE Trial. J Clin Med. 2020 Jun 1;9(6):1678. doi: 10.3390/jcm9061678.
    Results Reference
    derived

    Learn more about this trial

    Cilostazol and Endothelial Progenitor Cell

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