Myocardial Infarction, Acute Clinical Trial
— EPISODEOfficial 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
Verified date | May 2020 |
Source | Gyeongsang National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | July 31, 2020 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gyeongsang National University Hospital | Korea Otsuka Pharmaceutical Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline CD133+/KDR+ at 30 days | Peripheral blood mononuclear cells measurement by flow cytometry | baseline and 30 days | |
Primary | Changes from baseline CD34+/KDR+ at 30 days | Peripheral blood mononuclear cells measurement by flow cytometry | baseline and 30 days | |
Secondary | Levels of Platelet inhibition | Platelet function test by VerifyNow assay at 30-day follow-up | baseline and 30 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Incidence of bleeding events by BACR definition | Safety outcome | 30 days |
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