2023-503673-38-00已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Amgen Inc.393 个研究点 分布在 6 个国家目标入组 6,020 人开始时间: 2019年6月18日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,020
- 试验地点
- 393
- 主要终点
- Time to CHD death, MI, or ischemic stroke, whichever occurs first
研究概览
简要总结
To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first, in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for CHD death, MI, ischemic stroke, or any ischemiadriven arterial revascularization, whichever occurs first, in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy
研究设计
- 分配方式
- Randomized
- 主要目的
- 1 Period With 2 Arms (1 Arm With Evolocumab And 1 Arm With Placebo).
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects must be ≥ 50 years (men) or ≥ 55 years (women) to < 80 years of age (either sex) and meeting lipid criteria
- •Lipid Criteria (see Section 11.8 for permissible concomitant lipid-lowering therapy): Subjects must have an LDL-C ≥ 90 mg/dL (≥ 2.3 mmol/L) OR non-high density lipoprotein (HDL)-C ≥ 120 mg/dL (≥ 3.1 mmol/L) OR apolipoprotein B ≥ 80 mg/dL (≥ 1.56 umol/L)
- •Diagnostic evidence of at least 1 of the following (A - D) at screening: A. Significant coronary artery disease meeting at least 1 of the following criteria: - History of coronary revascularization with multi-vessel coronary disease as evidenced by any of the following: -(a) percutaneous coronary intervention (PCI) of 2 or more vessels, including branch arteries -(b) PCI or coronary artery bypass grafting (CABG) with residual ≥ 50% stenosis in a separate, unrevascularized vessel, or -(c) multi-vessel CABG 5 years or more prior to screening - Significant coronary disease without prior revascularization as evidenced by either a ≥ 70% stenosis of at least 1 coronary artery, ≥ 50% stenosis of 2 or more coronary arteries, or ≥ 50% stenosis of the left main coronary artery. - known coronary artery calcium score ≥ 100 in subjects without a coronary artery revascularization prior to randomization. B. Significant atherosclerotic cerebrovascular disease meeting at least 1 of the following criteria: -prior transient ischemic attack with ≥ 50% carotid stenosis -internal or external carotid artery stenosis of ≥ 70% or 2 or more ≥ 50% stenoses -prior internal or external carotid artery revascularization C. Significant peripheral arterial disease meeting at least 1 of the following criteria: - ≥ 50% stenosis in a limb artery -history of abdominal aorta treatment (percutaneous and surgical) due to atherosclerotic disease -ankle brachial index (ABI) < 0.85 D. Diabetes mellitus with at least 1 of the following: -known microvascular disease, defined by diabetic nephropathy or treated retinopathy. Diabetic nephropathy defined as persistent microalbuminuria (urinary albumin to creatinine ratio ≥ 30mg/g) and/or persistent estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 that is not reversible due to an acute illness -chronic daily treatment with an intermediate or long-acting insulin -diabetes diagnosis ≥ 10 years ago
- •At least 1 of the following high-risk criteria (most recent lab values within 6 months prior to screening, as applicable): - polyvascular disease, defined as coronary, carotid, or periperal artery stenosis > 50% in a seocnd distinct vasuclar location in a patient with coronary, cerebral of peripheral arterial diseasse (A, B or C above). - present of either diabetes mellitus or metabolic syndrome (Section 11.9) in a subject with coronary, cerebral, or peripheral artery disease (A, B or C above) -at least 1 coronary, carotid or periperal artery residual stenosis of > 50% in a patient with daibetes meeting inclusion criterion D above) - LDL-C > 130mg/dL (> 3.36 mmol/L), OR non-HDL-C > 160 mg/dL (> 4.14 mmol/L), OR apolipoprotein B > 120 mg/dL (2.3 µmol/L) if available -lipoprotein (a) > 125 nmol/L (50 mg/dL) - known familial hypercholesterolemia -family history of premature coronary artery disease defined as an MI or CABG in the subject's father or brother at age < 55 years or an MI or CABD in the subject's monther or sister at age < 60 years -high sensitive c-reactive protein (hsCRP) > 3.0 mg/L in the absence of an acute illness - current tobacco use - > 65 years of age - menopause before 40 years of age - eGFR 15 to 45 mL/min/1.73 m2 - coronary artery calcification score > 300 in a patient without a coronary revascularization prior to randomization
排除标准
- •MI or stroke prior to randomization
- •CABG < 3 months prior to screening
- •eGFR < 15 mL/min/1.73 m2
- •Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
- •Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low-molecular weight heparin, fondaparinux, or non-Vitamin K antagonist oral anticoagulant)
- •Triglycerides ≥ 500mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
- •Last measured left-ventricular ejection fraction < 30% or New York Heart Association (NYHA) Functional Class III/IV
- •Planned arterial revascularization
研究组 & 干预措施
Placebo for AMG 145
Placebo
干预措施: Placebo for AMG 145 (Drug)
EVOLOCUMAB
Test
干预措施: EVOLOCUMAB (Drug)
结局指标
主要结局
Time to CHD death, MI, or ischemic stroke, whichever occurs first
Time to CHD death, MI, or ischemic stroke, whichever occurs first
Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first
Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first
次要结局
- Time to cardiovascular death, MI, or ischemic stroke
- Time to CHD death or MI
- Time to MI
- Time to any ischemia-driven arterial revascularization
- Time to CHD death
- Time to cardiovasular death
- Time to all cause of death
- Time to ischemic stroke
- Time to MI, ischemic stroke, or any ischemia-driven arterial revascularization
- Time to CHD death, MI, or any ischemia-driven arterial revascularization
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (393)
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