EUCTR2012-001398-97-DK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 Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease. FOURIER - Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk
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
- 27,500
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
- •4.1.1 Signed informed consent
- •4.1.2 Male or female = 40 to = 85 years of age at signing of informed consent
- •4.1.3 History of clinically evident cardiovascular disease as evidenced by ANY
- •of the following:
- •o diagnosis of myocardial infarction
- •o diagnosis of non-hemorrhagic stroke (TIA does not qualify as
- •stroke for inclusion)
- •o symptomatic peripheral arterial disease (PAD), as evidenced
- •by intermittent claudication with ankle-brachial index
- •(ABI) < 0.85, or peripheral arterial revascularization
- •procedure, or amputation due to atherosclerotic disease
- •Note: the proportion of subjects with history of MI or nonhemorrhagic stroke > 5 years prior to screening will be determined by the sponsor
- •4.1.4 At least 1 major risk factor or at least 2 minor risk factors below:
- •Major Risk Factors (1 Required):
- •o diabetes (type 1 or type 2)
- •o age = 65 years at randomization (and = 85 years at time of
- •informed consent)
- •o MI or non-hemorrhagic stroke within 6 months of screening
- •o additional diagnosis of myocardial infarction or non-hemorrhagic
- •stroke excluding qualifying MI or non-hemorrhagic stroke (a)
- •o current daily cigarette smoking
- •o history of symptomatic PAD (intermittent claudication with ABI
- •< 0.85, or peripheral arterial revascularization procedure, or
- •amputation due to atherosclerotic disease) if eligible by MI or
- •stroke history
- •Minor Risk Factors (2 Required):
- •o history of non-MI related coronary revascularization (a)
- •o residual coronary artery disease with = 40% stenosis in = 2 large vessels
- •o Most recent HDL-C < 40 mg/dL (1.0 mmol/L) for men
- •and < 50 mg/dL (1.3 mmol/L) for women by central laboratory
- •before randomization
- •o Most recent hsCRP > 2.0 mg/L by central laboratory before
- •randomization
- •o Most recent LDL-C = 130 mg/dL (3.4 mmol/L) or non-HDL-C
- •= 160 mg/dL (4.1 mmol/L) by central laboratory before
- •randomization
- •o metabolic syndrome (b)
- •4.1.5 Most recent fasting LDL-C = 70 mg/dL (= 1.8 mmol/L) or non-HDL-C
- •= 100 mg/dL (= 2.6 mmol/L) by central laboratory during screening after = 2 weeks of stable lipid lowering therapy per Appendix E
- •4.1.6 Most recent fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory before randomization
- •(a)Note: there is no time limit on additional qualifying medical history.
- •(b)Definition: metabolic syndrome for this protocol is defined as = 3 of the following (Alberti et al, 2009):
- •waist circumference > 102 cm (> 40 in.) for men and > 88 cm (> 35 in.) for women (Asian men, including Japanese > 90 cm; Asian women, except Japanese > 80 cm; Japanese women > 90 cm)
- •triglycerides = 150 mg/dL (1.7 mmol/L) by central laboratory at final 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)
- •systolic blood pressure (SBP) = 130 mmHg or diastolic BP (DBP) = 85 mmHg or hypertension treated with medication
- •fasting glucose = 100 mg/dL (= 5.6 mmol/L) by central laboratory at final screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •4.2.1 Subject must not be randomized within 4 weeks of their most recent MI or stroke
- •4.2.2 NYHA class III or IV, or last known left ventricular ejection fraction < 30%
- •4.2.3 Known hemorrhagic stroke at any time
- •4.2.4 Uncontrolled or recurrent ventricular tachycardia
- •4.2.5 Planned or expected cardiac surgery or revascularization within 3 months after randomization
- •4.2.6 Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg
- •4.2.7 Use of cholesteryl ester transfer protein (CETP) inhibition treatment, mipomersen, or lomitapide within 12 months prior to randomization. Fenofibrate therapy must be stable for at least 6 weeks prior to final screening at a dose that is appropriate for the duration of the study in the judgment of the investigator. Other fibrate therapy (and derivatives) are prohibited
- •4.2.8 Prior use of PCSK9 inhibition treatment other than evolocumab or use of evolocumab < 12 weeks prior to final lipid screening
- •4.2.9 Untreated or inadequately treated hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, and free thyroxine (T4) levels that are outside normal range at final screening
- •4.2.10 Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening
- •4.2.11 Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN as determined by central laboratory analysis at final screening
- •4.2.12 Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)
- •4.2.13 Personal or family history of hereditary muscular disorders
- •4.2.14 LDL or plasma apheresis within 12 months prior to randomization
- •4.2.15 Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years
- •4.2.16 CK > 5 times the ULN at final screening
- •4.2.17 Known major active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
- •4.2.18 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
- •4.2.19 Subject has received drugs via a systemic route that have known major interactions with background statin therapy (see Appendix F) within 1 month prior to randomization or is likely to require such treatment during the study period
- •4.2.20 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)
- •4.2.21 Female subject who has either (1) not used acceptable method(s) of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment with IP and for an additional 15 weeks after the end of treatment with IP, 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 bilate
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