ACCELerated Inhibition of Platelet Aggregation, Inflammation and Ischemia-reperfusion Injury by Adjunctive Cilostazol Loading in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events (MACE)
研究概览
简要总结
The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary intervention (PCI).
详细描述
In ACS patients, platelet activation, inflammation, and ischemia-reperfusion injury can be closely associated with the risk of post-PCI myonecrosis and ischemic events occurrence. In the ACCEL-AMI (Adjunctive Cilostazol versus high maintenance-dose ClopidogrEL in patients with Acute Myocardial Infarction)study, adjunctive cilostazol increased platelet inhibition compared with double-dose clopidogrel. Meanwhile, statins can reduce the extent of myonecrosis via limiting inflammation and myocardial infarct size by activating phosphatidylinositol-3-kinase (PI3K), ecto-5'-nucleotidase, Akt/endothelial nitric oxide synthase (eNOS), and the downstream effectors inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). Inhibition of PI3K, adenosine receptors, eNOS, iNOS, or COX-2 abrogates the protective effects of statins. In animal study, the combination of low-dose statin with cilostazol synergistically limits infarct size. Multiple studies have shown that cilostazol can influence inflammation and RISK pathway using the similar pathway with statin. This study will be performed to evaluate the role of adjunctive cilostazol in platelet inhibition, inflammation, and myonecrosis compared with standard treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •Non-ST-elevation ACS patients undergoing PCI within 48 hours after hospitalization
排除标准
- •ST segment elevation acute myocardial infarction
- •NSTE ACS with high-risk features warranting emergency coronary angiography
- •Oral anticoagulation therapy with warfarin
- •Use of pre-procedural glycoprotein IIb/IIIa inhibitor
- •Contraindication to antiplatelet therapy
- •AST or ALT ≥ 3 times upper normal
- •Left ventricular ejection fraction < 30%
- •WBC < 3,000/mm3, platelet < 100,000/mm3
- •Creatinine ≥ 3 mg/dl
- •stroke within 3 months
研究组 & 干预措施
DAPT
干预措施: Dual Anti-Platelet Therapy (DAPT) (Drug)
TAPT
干预措施: Triple Anti-Platelet Therapy (TAPT) (Drug)
结局指标
主要结局
Major adverse cardiovascular events (MACE)
时间窗: 1 month
Composite of cardiac death, MI and ischemia-driven target lesion revascularization (TLR)
次要结局
- MACE incidence according to P2Y12 reaction unit(1 month)
- P2Y12 reaction unit levels in the 2 arms(1 month)
- 24hr post-procedural variations from baseline of inflammation markers (IL-6, TNF-alpha, cell adhesion molecules (VCAM, ICAM, E-selectin)(1 month)
- post-procedural variations from baseline of hs-CRP levels in the 2 arms(1 month)
- ACUITY major/minor bleeding rate(1 month)
- any post-procedural increase of markers of myocardial injury above ULN(1 month)