RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 3,780
- 试验地点
- 1
- 主要终点
- Composite of cardiovascular death
研究概览
简要总结
The clinical efficacy of LDL-lowering therapy have been proven with strong evidences and more emphasized. However, there are also growing concerns that high-intensity statin would be related to increased risk of adverse effects. In addition, there was an inconsistency of efficacy of statin according to ethnic population. Asian population showed more profound LDL reduction not only from high potent statin but from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol was focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate lowering LDL-cholesterol level. Additive ezetimibe will also an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to fulfill sufficient LDL-cholesterol lowering effect. We will evaluate whether additive ezetimibe with rosuvastatin will have comparable clinical efficacy in terms of clinical outcomes and goal attainment of LDL-C compared to rosuvastatin monotherapy.
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
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-80 years
- •Documented CVD (cardiovascular disease), previous MI(Myocardial Infarction), ACS (Acute Coronary Syndrome), coronary revascularization and other arterial revascularization procedures, ischemic stroke, or PAD (peripheral artery disease)
排除标准
- •Active liver disease or persistent unexplained serum AST or ALT elevation more than 2 times the upper limit of normal range
- •Allergy or hypersensitivity to any statin or ezetimibe
- •Solid organ transplantation recipient
- •History of any adverse drug reaction requiring discontinuation of statin
- •Pregnant women, women with potential childbearing, or lactating women
- •Life expectancy less than 3 years
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- •Inability to understand or read the informed content
研究组 & 干预措施
High-intensity statin monotherapy
Statin monotherapy
干预措施: Rosuvastatin (Drug)
Statin plus ezetimibe combination therapy
Statin plus ezetimibe combination therapy
干预措施: Rosuvastatin plus ezetimibe (Drug)
结局指标
主要结局
Composite of cardiovascular death
时间窗: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Major cardiovascular event
时间窗: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
Composite of nonfatal stroke
时间窗: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)
次要结局
- Clinical efficacy of lipid lowering treatment(3years)
- Clinical safety of lipid lowering treatment(3years)
- statin discontinuation and intolerance(3years)
- Clinical adverse events(3years)