NCT00206310已完成3 期
Controlled Rosuvastatin Multinational Study in Heart Failure CORONA A Randomized, Double-Blind, Placebo Controlled Phase III Study With Rosuvastatin in Subjects With Chronic Symptomatic Systolic Heart Failure
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 5,013
- 试验地点
- 359
- 主要终点
- The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).
研究概览
简要总结
The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)
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
- Double
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator
排除标准
- •Acute myocardial infarction within 6 months before randomization
- •Treatment with any statin or other lipid lowering drug; or a medical condition that in the opinion of the investigator requires treatment with a statin or other lipid lowering drug
结局指标
主要结局
The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).
次要结局
- The secondary objectives are to evaluate the effects of rosuvastatin on:
- Total mortality
- Any coronary event defined as the combined endpoint of sudden death or fatal or non-fatal MI or Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) or defibrillation of ventricular fibrillation by an implant
- Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure
- Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure
研究者
研究点 (359)
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