A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Composite endpoint, including either of the following events:
研究概览
简要总结
The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.
详细描述
Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality. Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function. The aim of present study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.
Design: A prospective, randomised, placebo controlled study. 2 year treatment period.
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
- 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
- •Males and females above 18 years of age
- •Patients having been treated with chronic hemodialysis for at least 6 months
- •Patients with documented cardiovascular disease, at least one of the following
- •Angina pectoris
- •Previous Acute myocardial infarction
- •Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
- •Previous Transitory Cerebral Ischemia
- •Previous Apoplexia Cerebri
- •Symptoms of peripheral vascular disease
- •Written informed consent
排除标准
- •Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
- •Patients undergoing peritoneal dialysis
- •Any condition associated with a risk of poor compliance, as judged by investigator
- •Pregnant or breastfeeding
- •Participation in other clinical studies involving treatment with drugs.
结局指标
主要结局
Composite endpoint, including either of the following events:
- Acute Myocardial Infarction
- Angina Pectoris, leading to coronary investigation or intervention
- Transient Cerebral Ischemia (TCI)
- Apoplexia cerebri (stroke)
- Peripheral Vascular disease, new symptoms or worsening of old symptoms
- Death
次要结局
- - Efficacy, fatty acid profile for phospholipids fraction
- - Efficacy: diet registration, fish score
- - Thrombosis and/or stenosis of dialysis graft
- - Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
- - Effect on heart rate variability, substudy of 50 patients at baseline and after three months