NCT01245803Unknown4 期
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome
Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- peri-procedural myocardial damage
研究概览
简要总结
Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 year old
- •diagnosed as acute coronary syndrome
- •Plan to PCI
排除标准
- •STEMI patient
- •emergency PCI(<2h) for NSTE-ACS
- •History of liver disease and myopathy (ALT/AST>3 x upper limit of normal,CK>5 x upper limit of normal)
- •TG>500mg/dl,CCr<30ml/min
- •inflammatory disease
- •allergic to rosuvastatin
- •nephrotic syndrome,hypothyroidism,systemic lupus erythematosus,myeloma,et.al.
研究组 & 干预措施
rosuvastatin,one month,lipid lowering
Experimental
additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI
干预措施: additional rosuvastatin loading (Drug)
sugar pill, one month
Placebo Comparator
sugar pill is given 18-24hr and 4-6hr before PCI as control
干预措施: placebo control (Drug)
结局指标
主要结局
peri-procedural myocardial damage
时间窗: 48 hours after PCI
次要结局
- MACE(30 days after PCI)
研究者
研究点 (1)
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