NL-OMON47312已完成3 期
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH) - STRENGTH
Astra Zeneca0 个研究点目标入组 533 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 533
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Men or women, *18 years of age.
- •2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization
- •(Visit 2) and meet the following criteria, where the qualifying lipid parameters should be obtained from the same visit:
- •a. LDL-C <100 mg/dL (<2.59 mmol/L). Patient will also qualify if LDL-C *100 mg/dL
- •(*2.59 mmol/L) and if on a high-intensity or maximally tolerated moderate- or lowintensity
- •statin dose, with or without ezetimibe therapy, for at least 4 weeks (see
- •Appendix D). The maximum tolerated dosage of a statin is defined as the approved dose
- •per local label that the patient can tolerate without unacceptable adverse effects such as
- •muscle aches/pain/weakness or elevations in liver enzymes or creatine kinase (CK) that
- •are determined by the investigator to be clinically relevant and due to statin therapy.
- •b. TG *180 and < 500 mg/dL (*2.03 and < 5.65 mmol/L) and HDL-C
- •<42 mg/dL (1.09 mmol/L) for men or HDL-C <47 mg/dL (1.22 mmol/L)
- •3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria
- •(3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of
- •a. Any atherosclerotic CVD as defined by one or more of the following:
- •* previous clinical myocardial infarction (MI) *30 days prior to randomization
- •* percutaneous coronary intervention (PCI) including balloon angioplasty and
- •coronary stenting * 6 months prior to randomization
- •* coronary artery bypass grafting (CABG) *30 days prior to randomization
- •* coronary angiogram including computed tomography angiogram (CTA)
- •showing<=> 50% stenosis in at least one native or graft
- •* anginal symptoms with a defect documented by stress testing with nuclear perfusion
- •imaging or a wall motion abnormality determined by stress echocardiogram
- •* asymptomatic coronary ischemia documented by stress testing with nuclear
- •perfusion imaging or by stress echocardiogram
- •* peripheral vascular disease with symptoms of claudication and ankle brachial index
- •<0.9 performed by a vascular lab or angiogram (including CTA) showing <=> 50% stenosis)
- •* history of peripheral arterial revascularization (surgical or percutaneous) *30 days
- •prior to randomization
- •* carotid endarterectomy, carotid stenting or more than or equal to 50% stenosis in a carotid artery
- •determined by carotid ultrasound or angiogram *30 days prior to randomization
- •* history of abdominal aortic aneurysm confirmed by imaging, diagnosed *30 days prior to randomization
- •* ischemic stroke *30 days prior to randomization
- •* coronary calcium score >300 Agatston units (AU).
- •b. History of diabetes mellitus (type 1 or 2) and *40 years of age for men and *50 years of
- •age for women, plus one of the following risk factors:
- •* chronic cigarette smoking at screening (at least 1 cigarette per day for > 1 month)
- •* history of hypertension (blood pressure >140/90 mm Hg) or taking antihypertensive
- •* high-sensitivity C-reactive protein (hs-CRP) > 2.0 mg/L (19.05 nmol/L) determined
- •* history of albuminuria (urinary albumin:creatinine ratio [ACR] >30 mg/g).
- •c. Male patients >50 years of age or females >60 years of age, with at least one of the
- •following risk factors:
- •* family history (mother, father or sibling) of premature coronary hea
排除标准
- •1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl
- •esters, or corn oil.
- •2. Known hypersensitivity to fish and/or shellfish
- •3. Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4
- •weeks prior to Visit 2. Patients taking these agents may be considered for inclusion in the
- •study if these therapies have been discontinued for 4 weeks or more prior to Visit 2.However,
- •niacin or its analogues at a dose less than or equal to 250 mg/day is
- •permissible.
- •4. Statin naïve at Visit 1.
- •5. Use of simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg within 4 weeks prior to Visit 2.
- •Patients taking these agents may be considered for inclusion in the study if these therapies
- •have been discontinued and replaced with a protocol acceptable statin treatment that is
- •stabilized for 4 weeks or more prior to Visit 2.
- •6. Use of any prescription medications containing eicosapentaenoic acid (EPA) and/or
- •docosahexaenoic acid (DHA), e.g. Lovaza® or Vascepa®, within 4 weeks prior to Visit 2.
- •Patients taking these agents may be considered for inclusion in the study if these therapies have been discontinued for 4 weeks or more prior to Visit 2.
- •7. More than one capsule/day (any dose) of omega-3 dietary
- •supplements. Patients taking >1 capsule/day of omega-3 supplements
- •before Visit 1 DO NOT require a washout period but must agree to
- •reduce the number of capsules per day to no more than 1 capsule of 1 g
- •promptly after signing the informed consent. No new omega-3
- •supplements are permitted following initiation of screening procedures
- •at Visit 1.
- •8. Use of prescription or over-the-counter (OTC) weight loss drugs at any time after Visit 1.
- •9. Chronic use of oral corticosteroids during screening (acute use for inflammation for example
- •from poison ivy, or intranasal or inhaled steroids for allergies/asthma, or intraarticular
- •injections are allowed).
- •10. Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for >4
- •weeks at Visit 1, or is unstable prior to Visit 2.
- •11. Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency.
- •12. Hemoglobin A1c (Hb A1c) >12% at Visit 1.
- •13. Poorly controlled hypertension (resting blood pressure *180 mm Hg systolic and/or *100
- •mm Hg diastolic) at two consecutive visits prior to randomization at Visit 2.
- •14. Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >2.0 times upper limit
- •of normal (ULN) at Visit 1. Patients who are clinically euthyroid, on stable thyroid
- •replacement therapy for 2 months prior to Visit 1 are allowed.
- •15. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within
- •the previous two years.
- •16. Patients on dialysis.
- •17. Females who are pregnant, planning to be pregnant during the study period, lactating, or
- •women of childbearing potential who are not using an acceptable method of contraception. A
- •woman is considered of childbearing potential if she is not surgically sterile or if her last
- •menstrual period was <12 months prior to Visit 1. Acceptable methods of contraception for
- •this study include use of double barrier contraception, intrauterine device, all
- •oral, patch, etc. hormonal contraceptives as long as dose and type is stable for 3 months prior
- •to Visit 1. In ad
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