NCT03494270已完成4 期
A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Compare High-intensity Rosuvastatin to Moderate-intensity Rosuvastatin/Ezetimibe in Atherosclerotic Cardiovascular Disease (ASCVD) Patients
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2018年3月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change from baseline to week 12 in LDL-C level
研究概览
简要总结
This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 to 75 years
- •Patients diagnosed with ASCVD (coronary artery disease)
- •acute coronary syndrome
- •history of myocardial infarction (MI)
- •stable or unstable angina
- •history of coronary revascularization
- •stroke or transient ischemic attack (TIA)
- •peripheral arterial disease, history of peripheral arterial revascularization
- •Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization
- •Written informed consent
排除标准
- •Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit
- •Fasting triglyceride ≥ 400 mg/dL
- •History of muscular disease or rhabdomyolysis due to use of statin
- •Hypersensitive to rosuvastatin or ezetemibe
- •Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
- •① Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
- •② ALT, AST > 3x ULN or history of active liver disease
- •③ CPK > 3x ULN
- •Administration of other investigational products within 30 days prior to screening visit
- •Other than the above who is deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
Rosuvamibe Tab
Experimental
Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks
干预措施: Rosuvamibe (Drug)
Monorova Tab
Active Comparator
Rosuvastatin 20mg qd for 24 weeks
干预措施: Monorova (Drug)
结局指标
主要结局
Change from baseline to week 12 in LDL-C level
时间窗: Baseline, Week 12
次要结局
- Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), Non-HDL cholesterol, Apolipoprotein A1, and Apolipoprotein B(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)(Baseline, Week 12, Week 24)
- Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)(Baseline, Week 12, Week 24)
- Proportion of subjects achieving LDL-C < 70mg/dL(Baseline, Week 12, Week 24)
- Occurrence of Statin-Associated Muscle Symptoms (SAMS)(Up to 24 weeks)
- Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN(Baseline, Week 12, Week 24)
- Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN(Baseline, Week 12, Week 24)
- Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)(Up to 24 weeks)
研究者
研究点 (1)
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