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
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Changes from baseline CD133+/KDR+ at 30 days
研究概览
简要总结
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)
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •naïve AMI
- •undergoing successful coronary stent implantation
排除标准
- •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
研究组 & 干预措施
CILO group
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.
干预措施: Cilostazol Tablets (Drug)
CILO group
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.
干预措施: Aspirin (Drug)
CILO group
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.
干预措施: Clopidogrel (Drug)
Placebo group
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.
干预措施: placebo (Drug)
Placebo group
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.
干预措施: Aspirin (Drug)
Placebo group
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.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Changes from baseline CD133+/KDR+ at 30 days
时间窗: baseline and 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
Changes from baseline CD34+/KDR+ at 30 days
时间窗: baseline and 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
次要结局
- Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method(baseline and 30 days)
- Incidence of bleeding events by BACR definition(30 days)
- Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow(baseline and 30 days)
- Levels of Platelet inhibition(baseline and 30 days)
研究者
Yongwhi Park, MD, PhD.
Principal investigator
Gyeongsang National University Hospital