Myocardial Infarction, Acute
Conditions
Keywords
Endothelial progenitor cell, Myocardial infarction, acute, Platelets, Cilostazol
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)
Interventions
DRUGCilostazol Tablets
Cilostazol-SR, capsule, 200mg, once daily, 30 days.
DRUGplacebo
Placebo, tablet, 200mg, once daily, 30 days.
DRUGAspirin
Astrix, capsule,100mg, once daily, 30 days.
DRUGClopidogrel
Plavix, tablet, 75mg, once daily, 30 days.
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Gyeongsang National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline CD133+/KDR+ at 30 days | baseline and 30 days | Peripheral blood mononuclear cells measurement by flow cytometry |
| Changes from baseline CD34+/KDR+ at 30 days | baseline and 30 days | Peripheral blood mononuclear cells measurement by flow cytometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Platelet inhibition | baseline and 30 days | 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 | baseline and 30 days | 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 | baseline and 30 days | the correlation between the changes of EPC subsets and ∆PRU by Pearson's method |
| Incidence of bleeding events by BACR definition | 30 days | Safety outcome |
Outcome results
None listed