Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- % change of low-density lipoprotein cholesterol
研究概览
简要总结
This study is a multicenter, randomized, open-label, parallel, phase IV trial.
The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.
详细描述
The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.
The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 75 years
- •Presence of atherosclerotic cardiovascular disease Coronary artery disease
- •History of acute coronary syndrome
- •Stable or unstable angina
- •History of coronary revascularization Stroke or TIA Peripheral arterial disease, history of peripheral arterial revascularization
- •Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
- •Patients who gave informed consent
排除标准
- •Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months
- •A serum triglyceride on fasting >400 mg/dL
- •A history of muscular symptoms or rhabdomyolysis due to the use of statin
- •Hypersensitivity to rosuvastatin or ezetimibe
- •Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl <30 mL/min by Cockcroft-Gault formula or estimated GFR <30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN
- •Enrollment of other clinical trials within 30 days
- •Any other issues that the treating physician assumes ineligible for participation in the trial
研究组 & 干预措施
combination therapy group
The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
干预措施: Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin (Drug)
intensive statin group
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
干预措施: Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin (Drug)
结局指标
主要结局
% change of low-density lipoprotein cholesterol
时间窗: at 12 weeks
%change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline \* 100
次要结局
- % change of fasting glucose(at 12 and 24 weeks)
- % change of serum cholesterol level(at 12 and 24 weeks)
- proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE)(at 12 and 24 weeks)
- % change of high-sensitivity C-reactive protein(at 12 and 24 weeks)
- % change of homeostatic model assessment for insulin resistance(HOMA-IR)(at 12 and 24 weeks)
- proportion of participant with statin-associated muscle symptoms(at 12 and 24 weeks)
- proportion of participant with creatinine phosphokinase elevation(at 12 and 24 weeks)
- proportion of participant with liver function test abnormality(at 12 and 24 weeks)
研究者
Si-Hyuck Kang
Principal Investigator
Seoul National University Bundang Hospital