Clinical trial NCT04407312: Cilostazol and Endothelial Progenitor Cell
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction, Acute
Keywords: Endothelial progenitor cell
Myocardial infarction, acute
Platelets
Cilostazol
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2020-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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)

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

Primary outcomes:
measure: Changes from baseline CD133+/KDR+ at 30 days
timeFrame: baseline and 30 days
measure: Changes from baseline CD34+/KDR+ at 30 days
timeFrame: baseline and 30 days
Secondary outcomes:
measure: Levels of Platelet inhibition
timeFrame: baseline and 30 days
measure: Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method
timeFrame: baseline and 30 days
measure: Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow
timeFrame: baseline and 30 days
measure: Incidence of bleeding events by BACR definition
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Gyeongsang National University Changwon Hospital
name: Young-Hoon Jeong, MD,.PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.