NCT02104817已完成3 期
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 13,078
- 试验地点
- 1
- 主要终点
- The Composite of Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, ≥18 years of age.
- •Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
- •LDL-C <100 mg/dL
- •TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
- •Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of screening:
- •Any atherosclerotic CVD as defined in protocol.
- •History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
- •Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.
排除标准
- •Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit
- •3.Statin naïve at Visit 1.
研究组 & 干预措施
EPANOVA
Experimental
Epanova + statin, once daily
干预措施: Epanova® (omega-3 carboxylic acids) (Drug)
Corn oil
Active Comparator
Corn oil + Statin
干预措施: corn oil control (Drug)
结局指标
主要结局
The Composite of Major Adverse Cardiovascular Events (MACE)
时间窗: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
次要结局
- The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- CV Death(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- All-cause Death in the Subgroup of Participants With Established CVD at Baseline(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- The Composite of CV Events(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- The Composite of Coronary Events(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- All-cause Death(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- CV Death in the Subgroup of Participants With Established CVD at Baseline(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
- The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline(From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
研究者
研究点 (1)
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