NCT00143507已完成3 期
Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-year Randomised Double-blind Placebo-controlled International Multicentre Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10,917
- 试验地点
- 1
- 主要终点
- Primary Composite Endpoint
研究概览
简要总结
The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Coronary artery disease
- •Left ventricular systolic dysfunction
- •Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)
排除标准
- •Unstable cardiovascular condition
- •Severe congestive heart failure
研究组 & 干预措施
Ivabradine
Experimental
干预措施: Ivabradine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Composite Endpoint
时间窗: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.
First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).
次要结局
- Coronary Artery Disease Death(From the date of randomisation to death, up to 3 years.)
- All-cause of Mortality(From the date of randomisation to death, up to 3 years.)
- Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
- Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
- Hospitalisation for Acute Myocardial Infarction(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
- Hospitalisation for New Onset or Worsening Heart Failure(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
- Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
- Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
- Cardiovascular Death(From the date of randomisation to death, up to 3 years.)
- Hospitalisation for Coronary Revascularisation(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
- Hospitalisation for Unstable Angina(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
- Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction(From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.)
研究者
研究点 (1)
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