Cilostazol and Endothelial Progenitor Cell

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Myocardial Infarction, Acute

Intervention / Treatment
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* Drug: Cilostazol Tablets
* Drug: placebo
* Drug: Aspirin
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CILO group<br>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<br>* Cilostazol-SR, capsule, 200mg, once daily, 30 days.<br>* Other names: Cilostazol-SR;Drug: Aspirin<br>* Astrix, capsule,100mg, once daily, 30 days.<br>* Other names: Astrix;Drug: Clopidogrel<br>* Plavix, tablet, 75mg, once daily, 30 days.<br>* Other names: Plavix;|
| Placebo Comparator: Placebo group<br>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: placebo<br>* Placebo, tablet, 200mg, once daily, 30 days.<br>Drug: Aspirin<br>* Astrix, capsule,100mg, once daily, 30 days.<br>* Other names: Astrix;Drug: Clopidogrel<br>* Plavix, tablet, 75mg, once daily, 30 days.<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial progenitor cell, Myocardial infarction, acute, Platelets, Cilostazol