A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease - AMG145-20110118 FOURIER

Amgen0 个研究点目标入组 998 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•* 40 to * 85 years of age
•history of clinically evident cardiovascular disease as signified by a recent (within 5 years) myocardial infarction or non-hemorrhagic strokeor symptomatic PAD (intermittent claudication with ankle-brachial index [ABI] < 0.85, or peripheral arterial revascularization procedure or amputation due to atherosclerotic disease);
•either history of type 2 diabetes or, if not diabetic, one of the following: age * 65 years at randomization (and *85 at time of informed consent) the index event within 6 months of screening, an additional prior MI or non non-hemorrhagic stroke, current daily cigarette smokinghistory of symptomatic peripheral vascular disease, or * 2 additional risk factors, as detailed in the study protocol.
•In addition, after * 4 weeks of a stable lipid stabilisation therapy, LDL-C must be * 70 mg/dL (* 1.8 mmol/L) or non HDL-C must be * 100 mg/dL (> 2.6
•mg/dL). Fasting triglycerides must be * 400 mg/dL (4.5 mmol/L).

•New York Heart Failure Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%;
•uncontrolled or recurrent ventricular tachycardia systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg;
•thyroid stimulating hormone < 1.0 time lower limit of normal (LLN) or >1.5 times upper limit of normal (ULN),
•estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x ULN, creatine kinase (CK) > 5x ULN
•recipient of any major organ transplant (eg, lung, liver, heart, bone marrow);
•personal or family history of hereditary muscular disorders
•severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years
•known history of hemorrhagic stroke;
•major active infection, or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction;
•use of cholesterylester transfer protein (CETP) inhibition treatment within 12 months prior to randomization;
•prior use of PCSK9 inhibition treatment other than AMG 145.
•The following lipid-lowering therapies are excluded for 6 weeks prior to screening and during the duration of the
•study: prescription lipid-regulating drugs other than statins and ezetimibe (eg, bile-acid sequestering resins,
•fibrates and derivatives), niacin (> 200 mg QD), and red yeast rice.
•Pregnancy, inadequate contraception, breast feeding

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