OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,800
- 试验地点
- 9
- 主要终点
- Sudden cardiac death
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.
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
- •Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)
- •Ability to take Ω-3-FAE or olive oil without risk
- •Informed consent
排除标准
- •Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation)
- •Known hypersensitivity to study medication
- •Dislike of fish oil
- •Haemorrhagic diathesis
- •Unwillingness to discontinue other medications containing fish oil
- •Legal incapacity
- •History of drug or alcohol abuse within 6 months
- •Any investigational therapy within one month of signing informed consent form
研究组 & 干预措施
1
omega-3-acid ethyl ester 90
干预措施: Zodin (drug) (Drug)
2
olive oil
干预措施: Olive oil (placebo) (Drug)
结局指标
主要结局
Sudden cardiac death
时间窗: 12 months
次要结局
- Total mortality(12 months)
- MACCE: Total mortality, re-infarction or stroke(12 months)
- Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days(12 months)
- Total rehospitalisation(12 months)
- Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)(12 months)
- Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).(12 months)
- Effect on the severity of depressive co-morbidity in patients surviving an acute myocardial infarction for one year: Mean BDI-II-Depression score and percentage of patients with BDI-II score ≥ 14(after 12 months)
- Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months(12 months)
- Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months(12 months)