In Silico Non Interventional Secondary Use of Data Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204,691
- 试验地点
- 1
- 主要终点
- Time to the first occurrence between trial start and end of follow-up of any component of 3P-MACE (composite of CV death, non-fatal MI or non-fatal ischemic stroke)
研究概览
简要总结
Study CKJX839B1FR01 in an In silico trial to predict the efficacy of Inclisiran therapy on major adverse cardiovascular events (MACE) and cardiovascular (CV) death in virtual patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.
详细描述
Purpose of this study is to predict the size of efficacy of inclisiran 300 mg s.c., administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in addition to currently available lipid lowering therapies (LLTs) on a 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, and on CV death, in a secondary prevention cohort of ASCVD virtual patients with a LDL-C ≥ 70 mg/dL. This will be compared to 1) placebo in adjunct to high-intensity statin therapy with or without ezetimibe, 2) ezetimibe in adjunct to high-intensity statin therapy, 3) Evolocumab in adjunct to high-intensity statin therapy and ezetimibe.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（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
Virtual Patient with ASCVD
Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control.
干预措施: Inclisiran sodium (Drug)
Virtual Patient with ASCVD
Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control.
干预措施: Placebo (Drug)
Virtual Patient with ASCVD
Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control.
干预措施: Ezetimibe (Drug)
Virtual Patient with ASCVD
Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control.
干预措施: Evolocumab (Drug)
结局指标
主要结局
Time to the first occurrence between trial start and end of follow-up of any component of 3P-MACE (composite of CV death, non-fatal MI or non-fatal ischemic stroke)
时间窗: 5 years of follow-up
3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.
Time to the first occurrence between trial start and end of follow-up of CV death
时间窗: 5 years of follow-up
CV death is defined as death due to cardiovascular events
次要结局
- Time to the first occurrence between trial start and end of follow-up of ischemic stroke (non-fatal or fatal)(5 years of follow-up)
- Time to the first occurrence between trial start and end of follow-up of MI (non-fatal or fatal)(5 years of follow-up)
- Time to the first occurrence between trial start and end of follow-up of Major Adverse Limb events (MALE)(5 years of follow-up)
- Change in LDL-C from baseline to specified time points(baseline, day 1, 30, 90 and every 6 months afterwards will be presented and additional time points could be added if deemed necessary.)
- Time adjusted percentage change in LDL-C(From baseline between Day 90 and the end of follow-up period (up to 5 years))