A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate 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
- 招募中
- 发起方
- 入组人数
- 7,990
- 试验地点
- 21
- 主要终点
- Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable angina
研究概览
简要总结
This is a multi-center, multi-national, prospective, randomized, double-blind, placebo controlled, parallel-group study. This is an event-driven trial: Approximately 7990 patients will be randomized at multiple research sites worldwide including 22 sites in India, over a planned period of 18 months. After randomization, patients will be treated with AMR101 4 g daily with statin, or Placebo with statin. The patients will be followed over 3.25-4.75 years with a planned median follow-up of 4 years. The study end date is determined to be when sufficient primary efficacy events have occurred.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢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
- •â€¢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 fish oil products •History of acute or chronic pancreatitis •Patients are excluded if using the following medications: oniacin 200 mg/day or fibrates; oany omega-3 fatty acid medications; odietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil); obile acid sequestrants.
结局指标
主要结局
Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable angina
时间窗: 4-6 years
次要结局
- Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc.(4-6 years)