Cilostazol and Endothelial Progenitor Cell
Phase 4
- Conditions
- Myocardial Infarction, Acute
- Interventions
- Registration Number
- NCT04407312
- Lead Sponsor
- Gyeongsang National University Hospital
- 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CILO group Cilostazol Tablets 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 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. CILO group Aspirin 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. CILO group Clopidogrel 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 Aspirin 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. Placebo group Clopidogrel 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Incidence of bleeding events by BACR definition 30 days Safety outcome
Levels of Platelet inhibition baseline and 30 days Platelet function test by VerifyNow assay at 30-day follow-up
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