NCT00382460已完成4 期
Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)
Bristol-Myers Squibb0 个研究点目标入组 4,000 人开始时间: 2000年11月最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 主要终点
- To demonstrate the clinical equivalence of pravastatin 40 mg and atorvastatin 80 mg in reducing death or major cardiovascular event after 2 years
研究概览
简要总结
The primary purpose of the study was to evaluate 4000 subjects with acute coronary syndrome by comparing pravastatin 40 mg to atorvastatin 80 mg to determine if they are clinically equivalent, and to evaluate the effectiveness of gatifloxacin therapy in reducing cardiovascular events in combination with statin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
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
- •Hospitalization for MI or high risk unstable angina within the last 10 days.
- •Total cholesterol 240 mg/dl or greater.
- •Stabilized post ACS
排除标准
- •Co-morbidity with life expectations no more than 2 years.
- •Current lipid lowering therapy
- •Corrected QT interval
- •Need for Class IA or III antiarrhythmic agent
结局指标
主要结局
To demonstrate the clinical equivalence of pravastatin 40 mg and atorvastatin 80 mg in reducing death or major cardiovascular event after 2 years
To demonstrate in subjects with ACS that Gatifloxacin is effective in reducing death or major cardiovascular event after 2 years, compared to placebo.
次要结局
- To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo.
研究者
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