Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,179
- 试验地点
- 1
- 主要终点
- Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
研究概览
简要总结
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and non-pregnant or sterile women ages 45 and older
- •Hypertriglyceridemia
- •On statin therapy for at least four weeks
- •Either having established cardiovascular disease or at high risk for cardiovascular disease
排除标准
- •Severe heart failure
- •Any life-threatening disease other than cardiovascular disease
- •Active severe liver disease
- •Hemoglobin A1c >10.0%
- •Poorly controlled hypertension
- •Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
- •Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
- •Known hypersensitivity to the study product, fish and/or shellfish, or placebo
- •History of acute or chronic pancreatitis
- •Patients are excluded if using the following medications:
- •PCSK9 inhibitors
- •niacin >200 mg/day or fibrates;
- •any omega-3 fatty acid medications ;
- •dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
- •bile acid sequestrants
研究组 & 干预措施
Placebo
Placebo + statin therapy, daily
干预措施: Statin therapy (Drug)
AMR101
AMR101 (icosapent ethyl) + statin therapy, daily
干预措施: AMR101 (Drug)
AMR101
AMR101 (icosapent ethyl) + statin therapy, daily
干预措施: Statin therapy (Drug)
Placebo
Placebo + statin therapy, daily
干预措施: Placebo (Drug)
结局指标
主要结局
Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
时间窗: Total follow-up time of up to approximately 6 years.
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
次要结局
- Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.(Total follow-up time of up to approximately 6 years.)
- Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.(Total follow-up time of up to approximately 6 years.)
- CV Death.(Total follow-up time of up to approximately 6 years.)
- Fatal or Nonfatal Stroke.(Total follow-up time of up to approximately 6 years.)
- Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.(Total follow-up time of up to approximately 6 years.)
- Fatal or Nonfatal MI (Including Silent MI).(Total follow-up time of up to approximately 6 years.)
- Composite of CV Death or Nonfatal MI (Including Silent MI).(Total follow-up time of up to approximately 6 years.)
- Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.(Total follow-up time of up to approximately 6 years.)
- Total Mortality.(Total follow-up time of up to approximately 6 years.)