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| Name | Class |
|---|---|
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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)
Primary endpoint: % Change of EPC count
Secondary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CILO group | Experimental | 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. |
|
| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol Tablets | Drug | Cilostazol-SR, capsule, 200mg, once daily, 30 days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Hoon Jeong, MD,.PhD | Gyeongsang National University Changwon Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32492942 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | Placebo, tablet, 200mg, once daily, 30 days. |
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| Aspirin | Drug | Astrix, capsule,100mg, once daily, 30 days. |
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| Clopidogrel | Drug | Plavix, tablet, 75mg, once daily, 30 days. |
|
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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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |