Cilostazol and Endothelial Progenitor Cell (EPISODE)

May 27, 2020 updated by: Yongwhi Park, MD, PhD., Gyeongsang National University Hospital

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

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CILO group

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.
Drug: Cilostazol Tablets
Cilostazol-SR, capsule, 200mg, once daily, 30 days.
Other Names:
  • Cilostazol-SR
Drug: Aspirin
Astrix, capsule,100mg, once daily, 30 days.
Other Names:
  • Astrix
Drug: Clopidogrel
Plavix, tablet, 75mg, once daily, 30 days.
Other Names:
  • Plavix
Placebo Comparator: Placebo group

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.
Drug: Aspirin
Astrix, capsule,100mg, once daily, 30 days.
Other Names:
  • Astrix
Drug: Clopidogrel
Plavix, tablet, 75mg, once daily, 30 days.
Other Names:
  • Plavix
Drug: placebo
Placebo, tablet, 200mg, once daily, 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline CD133+/KDR+ at 30 days
Time Frame: baseline and 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
baseline and 30 days
Changes from baseline CD34+/KDR+ at 30 days
Time Frame: baseline and 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
baseline and 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyeongsang National University Hospital

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Young-Hoon Jeong, MD,.PhD, Gyeongsang National University Changwon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNUHIRB 2012-01-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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