EUCTR2018-004565-14-SE进行中（未招募）1 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.0 个研究点目标入组 12,000 人开始时间: 2019年5月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •-Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •-Adult subjects = 50 years (men) or = 55 years (women) to < 80 years
- •of age (either sex) and meeting lipid criteria
- •-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 µmol/L)
- •1. Lipid entry criteria can be measured up to 3 months prior to screening in the absence of changes to background therapy
- •2. Lipid criteria should be assessed after = 2 weeks of stable, optimized
- •lipid-lowering therapy
- •3. The most recent results (historical or screening) must be used
- •-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
- •1. 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
- •2. Significant coronary disease without prior revascularization as
- •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
- •3. 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:
- •1. prior transient ischemic attack with = 50% carotid stenosis
- •2. internal or external carotid artery stenosis of = 70% or 2 or more =
- •50% stenoses
- •3. prior internal or external carotid artery revascularization
- •C. Significant peripheral arterial disease meeting at least 1 of the
- •following criteria:
- •1. = 50% stenosis in a limb artery
- •2. history of abdominal aorta treatment (percutaneous and surgical) due
- •to atherosclerotic disease
- •3. ankle brachial index (ABI) < 0.85
- •D. Diabetes mellitus with at least 1 of the following:
- •1. known microvascular disease, defined by diabetic nephropathy or
- •treated retinopathy. Diabetic nephropathy defined as persistent
- •microalbuminuria (urinary albumin to creatinine ratio = 30 mg/g)
- •and/or persistent estimated glomerular filtration rate (eGFR) < 60
- •mL/min/1.73 m2 that is not reversible due to an acute illness
- •2. chronic daily treatment with an intermediate or long-acting insulin
- •3. diabetes diagnosis = 10 years ago
- •- At least 1 of the following high risk criteria at screening (most recent
- •lab values within 6 months prior to screening, as applicable):
- •1. polyvascular disease, defined as coronary, carotid, or peripheral
- •artery stenosis = 50% in a second distinct vascular location in a patient
- •with coronary, cerebral or peripheral arterial disease (above inclusion
- •criterion A-C)
- 另有 8 项未显示
排除标准
- •Subjects are excluded from the study if any of the following criteria
- •1. Disease Related
- •- MI or stroke prior to randomization
- •- CABG < 3 months prior to screening
- •- 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)
- •- Last measured left-ventricular ejection fraction < 30% or New York
- •Heart Association (NYHA) Functional Class III/IV
- •- Planned arterial revascularization
- •2. Diagnostic Assessments
- •- Triglycerides = 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
- •- End stage renal disease (ESRD), defined as an eGFR < 15 mL/min/1.73
- •m2 or receiving dialysis measured up to 6 months prior to screening. The most recent results must be used.
- •3. Other Medical Conditions
- •- Malignancy (except non-melanoma skin cancers, cervical in situ
- •carcinoma, breast ductal carcinoma in situ, or stage 1 prostate
- •carcinoma) within the last 5 years prior to day 1
- •- History or evidence of clinically significant disease (eg, malignancy,
- •respiratory, gastrointestinal, renal or psychiatric disease) or unstable
- •disorder that, in the opinion of the investigator(s), Amgen physician or
- •designee would pose a risk to the patient's safety or interfere with the
- •study assessments, procedures, completion, or result in a life expectancy
- •of less than 1 year
- •- Persistent acute liver disease or hepatic dysfunction, defined as Child
- •Pugh score of C
- •4. Prior/Concomitant Therapy
- •- Previously received a cholesterol ester transfer protein (CETP) inhibitor
- •(ie, anacetrapib, dalcetrapib, evacetrapib), mipomersen, lomitapide, or
- •has undergone LDL-apheresis in the last 12 months prior to LDL-C
- •- Previously received or receiving any other therapy to inhibit PCSK9 in
- •the following timeframe prior to screening:
- •(a) bococizumab at any time
- •(b) evolocumab, alirocumab, or any other monoclonal antibody against
- •PCSK9 within 3 months
- •(c) inclisiran within 12 months
- •5. Prior/Concurrent Clinical Study Experience
- •- Currently receiving treatment in another investigational device or drug
- •study, or less than 30 days since ending treatment on another
- •investigational device or drug study(ies).
- •6. Other Exclusions
- •- Female subjects of childbearing potential unwilling to use 1 acceptable
- •method of effective contraception during treatment and for an additional
- •15 weeks after the last dose of investigational product.
- •- Subject has known sensitivity to any of the products or components to
- •be administered during dosing.
- •- Subject likely to not be available to complete all protocol-required
- •study visits or procedures, and/or to comply with all required study
- 另有 7 项未显示
研究者
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