A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 17,004
- 试验地点
- 1,262
- 主要终点
- Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
研究概览
简要总结
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
详细描述
Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin 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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting LDL-C ≥ 70 mg/dL at randomization visit
- •Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
- •Established CV disease defined as ANY of the following three conditions
- •Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
- •History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
- •Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.
排除标准
- •Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit
- •Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
- •Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
- •Heart failure NYHA class III or IV
- •Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
- •Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
- •Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
- •History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Inclisiran sodium
Subcutaneous injection
干预措施: Inclisiran sodium 300 mg (Drug)
Placebo
Subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
时间窗: From randomization to total follow-up time (up to 72 months)
3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.
次要结局
- Time to Occurrence of Cardiovascular (CV) Death(From randomization to total follow-up time (up to 72 months))
- Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)(From randomization to total follow-up time (up to 72 months))
- Time to first occurrence of Major Limb Adverse Events (MALE)(From randomization to total follow-up time (up to 72 months))
- Time to occurrence of all-cause death(From randomization to total follow-up time (up to 72 months))