A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,873
- 主要终点
- Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram.
排除标准
- •Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.
研究组 & 干预措施
EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
干预措施: ezetimibe (+) simvastatin (Drug)
结局指标
主要结局
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)
时间窗: Entire follow-up (median = 4.35 years)
Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke
次要结局
- Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)(Entire follow-up (median = 4.35 years))
- Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)(Entire follow-up (median = 4.35 years))
- Change From Baseline in Peak Transaortic Jet Velocity(Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement)