A Randomized, Open-label, Blinded Intravascular Ultrasound Analysis, Parallel Group, Multicenter Study to Evaluate the Effect of Praluent® (Alirocumab) on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia Not Adequately Controlled With Statin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 206
- 试验地点
- 39
- 主要终点
- Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
研究概览
简要总结
Primary Objective:
To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary atheroma progression (percent change in normalized total atheroma volume [TAV]) after 9 months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks prior to randomization, with hypercholesterolemia treated with statin.
Secondary Objectives:
- To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints including absolute change in percent atheroma volume and normalized TAV after 9 months of treatment.
- To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein cholesterol and lipoprotein (a) after 9 months treatment.
- To evaluate the safety of alirocumab (Praluent®) including the occurrence of cardiovascular events (coronary heart disease death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) throughout the study.
详细描述
The duration of study per participant was 9 months.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard of Care
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
干预措施: Atorvastatin (Drug)
Standard of Care
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
干预措施: Rosuvastatin (Drug)
Standard of Care
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
干预措施: Fenofibrate (Drug)
Standard of Care
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
干预措施: Bezafibrate (Drug)
Standard of Care
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
干预措施: Ezetimibe (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Ezetimibe (Drug)
Standard of Care
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
干预措施: Antiplatelets (Drug)
Standard of Care
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
干预措施: Anticoagulants (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Alirocumab SAR236553 (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Atorvastatin (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Rosuvastatin (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Fenofibrate (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Bezafibrate (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Antiplatelets (Drug)
Alirocumab
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
干预措施: Anticoagulants (Drug)
结局指标
主要结局
Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
时间窗: Baseline, Week 36
Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.
次要结局
- Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36(Baseline, Week 36)
- Percent Change From Baseline in Apolipoprotein B at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36(Baseline, Week 36)
- Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Total Cholesterol (TC) at Week 36(Baseline, Week 36)
- Percent Change From Baseline in Total Cholesterol at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Lumen Volume at Week 36(Baseline, Week 36)
- Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36(Baseline, Week 12, Week 36)
- Percent Change From Baseline in External Elastic Membrane Volume at Week 36(Baseline, Week 36)
- Percent Change From Baseline in Lumen Volume at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36(Baseline, Week 12, Week 36)
- Percent Change From Baseline in Lipoprotein (a) at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36(Baseline, Week 36)
- Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36(Baseline, Week 36)
- Percent Change From Baseline in Fasting Triglycerides at Week 36(Baseline, Week 36)
- Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36(Baseline, Week 36)
- Percent Change From Baseline in Apolipoprotein A-1 at Week 36(Baseline, Week 36)
- Number of Participants With Cardiovascular (CV) Adverse Events(Up to 36 weeks)