NCT02993406已完成3 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13,970
- 试验地点
- 1
- 主要终点
- Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years
- •History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
- •Participant-reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:
- •2 or more statins at any dose, or
- •1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.
- •Please note that participants currently tolerating very low dose statin therapy (an average daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin <2 mg) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.
- •Written confirmation by both participant and investigator that the participant is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other participants who are unable to tolerate a statin are able to tolerate a different statin or dose.
- •Men and nonpregnant, nonlactating women
- •Fasting blood LDL-cholesterol ≥ 100 (2.6 mmol/L) at screening
排除标准
- •Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
- •Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
- •History of severe heart failure
- •Uncontrolled hypertension or uncontrolled diabetes
研究组 & 干预措施
Bempedoic Acid 180 mg
Experimental
Bempedoic acid 180 mg tablet taken orally, once daily.
干预措施: Bempedoic acid 180 mg tablet (Drug)
Placebo Comparator
Placebo Comparator
Matching placebo tablet taken orally, once daily
干预措施: Matching placebo tablet (Drug)
结局指标
主要结局
Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
时间窗: Up to 68 months
The primary efficacy end point was a four-component composite of adjudicated MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, as assessed in a time-to first-event analysis.
次要结局
- Number of Participants With Time to First Occurrence of Coronary Revascularization(Up to 68 months)
- Number of Participants With First Occurrence of Myocardial Infarction(Up to 68 months)
- Number of Participants With First Occurrence of Three Component MACE(Up to 68 months)
- Number of Participants With Time to Cardiovascular Death(Up to 68 months)
- Number of Participants With Time to All-cause Mortality(Up to 68 months)
- Number of Participants With Time to First Occurrence of Stroke(Up to 68 months)
研究者
研究点 (1)
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