Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,027
- 试验地点
- 4
- 主要终点
- Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.
研究概览
简要总结
The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.
The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 70 Years 至 82 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute myocardial infarction discharged from hospital alive
排除标准
- •Being part of another randomized trial
- •Documented intolerance for omega-3 fatty acids
- •Additional disease state that is thought to be incompatible with compliance to the study drugs
- •Additional disease state thought to reduce survival for the follow-up time of 2 years
研究组 & 干预措施
Pikasol
Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
干预措施: Pikasol (Drug)
Corn oil
3x capsules of corn oil pr day
干预措施: Corn oil (Other)
结局指标
主要结局
Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure.
时间窗: 24months
次要结局
- Occurence of new onset atrial fibrillation(24months)
研究者
Are Annesønn Kalstad
Medical Doctor
Oslo University Hospital