EUCTR2012-001398-97-NO进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 27,564
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
- •Signed informed consent
- •Male or female = 40 to = 80 years of age at signing of informed consent
- •History of clinically evident cardiovascular disease within 5 years of screening as evidenced by ANY of the following:
- •o diagnosis of myocardial infarction
- •o diagnosis of stroke
- •History of type 2 diabetes or, if not diabetic, ANY of the following:
- •o age = 65 years (and = 80 years)
- •o index event within 6 months prior to screening
- •o additional diagnosis of myocardial infarction or stroke (prior to and excluding index event)
- •o history of symptomatic peripheral vascular disease (intermittent claudication with ankle-brachial index [ABI] < 0.9, or peripheral vascular revascularization procedure, or amputation due to atherosclerotic disease)
- •o = 2 of the following risk factors:
- •-HDL-C < 40 mg/dL (1.0 mmol/L) for men and < 50 mg/dL (1.3 mmol/L) for women by central laboratory at screening
- •-residual coronary artery disease with = 40% stenosis in = 2 large vessels
- •-hsCRP > 2.0 mg/L by central laboratory at screening
- •-current smoker
- •-age > 60 years
- •-history of non-MI related coronary revascularization*
- •-final LDL-C > 130 mg/dL (3.4 mmol/L) or non-HDL-C = 160 mg/dL (4.1 mmol/L) by central laboratory during screening
- •-metabolic syndrome, defined as = 3 of the following:
- •- waist circumference > 102 cm (> 40 in.) for men and > 88 cm (> 35 in.) for women
- •- triglycerides = 150 mg/dL (1.7 mmol/L) by central laboratory at screening
- •- HDL-C < 40 mg/dL (1.0 mmol/L) for men
- •and < 50 mg/dL (1.3 mmol/L) for women by central laboratory at screening (Note: if the HDL-C level is one of criterion used to make the diagnosis of metabolic syndrome, it cannot be used as a separate risk factor)
- •- blood pressure (BP) = 130 / = 85 mmHg
- •- fasting glucose = 110 mg/dL by central laboratory at screening
- •Fasting LDL-C = 70 mg/dL (= 1.8 mmol/L) ) or non-HDL-C = 100 mg/dL (> 2.6 mg/dL) by central laboratory during screening after = 4 weeks of stable dose of 20 mg, 40 mg, or 80 mg QD atorvastatin, with or without ezetimibe 10 mg QD
- •Fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9000
排除标准
- •NYHA class III or IV, or last known left ventricular ejection fraction < 30%
- •Known hemorrhagic stroke
- •Uncontrolled or recurrent ventricular tachycardia
- •Planned or expected cardiac surgery or revascularization within 3 months after randomization
- •Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg
- •In the 6 weeks prior to LDL-C screening, subject has taken red yeast rice, > 200 mg/day niacin, or prescription lipid-regulating drugs (eg, bile-acid sequestering resins, fibrates and derivatives) other than statins or ezetimibe
- •Use of cholesterylester transfer protein (CETP) inhibition treatment within 12 months prior to randomization
- •Prior use of PCSK9 inhibition treatment other than AMG 145
- •Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) < 1.0 time the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening
- •Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at screening
- •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by central laboratory analysis at screening
- •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
- •CK > 5 times the ULN at screening
- •Known active infection or major hematologic, renal, metabolic,
- •gastrointestinal or endocrine dysfunction in the judgment of the investigator
- •Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate
- •carcinoma) within the last 10 years
- •Subject has received drugs that are strong inhibitors of cytochrome P-450 3A4 (Itraconazole, ketoconazole, and other antifungal azoles, macrolide antibiotics erythromycin, clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, antidepressant nefazodone and grapefruit juice in large quantities [> 1 quart daily]) within 1 month prior to randomization or is likely to require such treatment during the study period
- •Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- •Female subject who has either (1) not used at least 1 highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilized or postmenopausal;
- •-menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female = 55 years old or 12 months
- •of spontaneous and continuous amenorrhea with a follicle stimulating hormone (FSH) level > 40 IU/L (or according to the definition of postmenopausal range for the laboratory involved) in a female < 55 years old unless the subject has undergone bilateral oophorectomy
- •- highly effective methods of birth control include not having intercourse or using birth control methods that work at least 99% of the time when used correctly and include: birth control pills, shots, implants, or patches, intrauterine devices (
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