A Prospective Randomized, Open-Label, Parallel-Group Comparative Study: Atorvastatin Pre-Treatment Versus Usual Care In Asian Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 499
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)
研究概览
简要总结
This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-ST elevated ACS; LDL-C > 80 mg/dl
排除标准
- •ST elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins
研究组 & 干预措施
Atorvastatin Group
干预措施: Atorvastatin (Drug)
Usual Care Group
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)
时间窗: 30 days post PCI
Percentage calculated as: (number of participants who experienced MACE \[death, myocardial infarction, target vessel revascularization\] within 30 days post-PCI) divided by (number of participants who experienced PCI) \* 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded.
次要结局
- Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)(8 hours, 24 hours and 30 days post PCI)
- Percentage of Participants With Elevated Myoglobin(8 hours, 24 hours and 30 days post PCI)
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI(8 hours post PCI)
- Percentage of Participants With Elevated Troponin I(8 hours, 24 hours and 30 days post PCI)
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI(24 hours post PCI)
- Percent Change From Baseline in C-Reactive Protein (CRP)(Baseline, 8 hours, 24 hours and 30 days)