A Phase 4, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Effectiveness and Safety of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 7
- 主要终点
- Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6
研究概览
简要总结
This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are ≥ 30 years old.
- •Patients with very high-risk*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020).
- •Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment
- •rosuvastatin < 10 mg, atorvastatin < 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020).
- •Patients with LDL-C levels ≥ 70 mg/dL
- •Patients who are willing to maintain TLC throughout the study.
- •Patients who are willing to provide written informed consent prior to study enrollment.
排除标准
- •Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients.
- •Patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) > 3 x upper limit of normal (ULN)).
- •Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease.
- •Patients with myasthenia gravis.
- •Female patients who are pregnant or have a potential to be pregnant and nursing.
- •Patients who are taking glecaprevir and pibrentasvir.
- •Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption.
- •Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia.
- •Patients with a history of cancer within 5 years.
- •Patients whose life expectancy is less than 6 months due to their medical conditions.
- •Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study.
- •Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period.
- •Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.
研究组 & 干预措施
Eze/Ato: Ezetimibe/Atorvastatin
Participants will receive ezetimibe/atorvastatin 10/40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C < 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target level is not reached at Visit 3, dose is increased to ezetimibe/atorvastatin 10/80 mg QD from Visit 3 to Visit 4.
干预措施: Atozet 10/40 mg or 10/80 mg (Drug)
Ato: Atorvastatin
Participants will receive atorvastatin 40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C < 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target is not reached at Visit 3, dose is increased to atorvastatin 80 mg QD from Visit 3 to Visit 4.
干预措施: Lipitor 40 mg or 80 mg (Drug)
结局指标
主要结局
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6
时间窗: Baseline (Day 1) and Week 6
Blood samples were collected to determine the LDL-C values. The percentage change from baseline was defined as 100 x (LDL-C value at 6 weeks - LDL-C value at baseline)/LDL-C value at baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date.
次要结局
- Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12(Weeks 6 and 12)
- Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12(Weeks 6 and 12)
- Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12(Baseline (Day 1) and Week 12)
- Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12(Baseline (Day 1) and Weeks 6 and 12)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12(From the first dose administration of the study treatment (Day 1) up to Week 6; From the first dose administration of the study treatment (Day 1) up to Week 12)
- Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study(From the first dose administration of the study treatment (Day 1) up to Week 6; From the first dose administration of the study treatment (Day 1) up to Week 12)