EUCTR2021-002343-30-HU进行中（未招募）1 期
A randomized trial of evolocumab on saphenous vein graft patency following coronary artery bypass surgery (NEWTON-CABG) - NEWTON-CABG
nity Health Toronto, at its St. Michael’s site0 个研究点目标入组 666 人开始时间: 2021年7月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 666
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
- •To be considered eligible for participation in this study, a participant must satisfy each of the following criteria:
- •1.Age = 18 years
- •2.Scheduled to undergo coronary artery bypass graft (CABG) surgery (with or without cardiopulmonary bypass (CPB); with or without single valve repair/replacement)
- •3.CABG procedure included/planned to include at least two saphenous vein grafts
- •4.CABG procedure occurred within the past 21 days, or is planned within the next 60 days
- •5.On a moderate to high intensity statin therapy (defined as atorvastatin 40-80 mg daily, rosuvastatin 20-40 mg, or simvastatin 40 mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 466
排除标准
- •A participant will be ineligible for participation in this study if he or she satisfies any one or more of the following criteria:
- •1.Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
- •2.Allergy to contrast dye
- •3.Known severe hepatic impairment (Childs-Pugh, Class C).
- •4.Known renal disease with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- •5.Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow)
- •6.Use of cholesterylester transfer protein (CETP) inhibition treatment within 12 months prior to randomization.
- •7.Current, prior within past year, or known planned use of PCSK9 inhibition treatment
- •8.Severe cardiovascular or concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 2 years
- •9.Major active infection, or major hematologic, renal, respiratory, metabolic, gastrointestinal or endocrine dysfunction
- •10.Women who are pregnant or breastfeeding
- •11.Women of child bearing potential who are unwilling to use proper family planning or birth control methods to avoid pregnancy. Women are considered post-menopausal and not of childbearing potential after 12 months of natural (spontaneous) amenorrhea or have had a surgical procedure such as hysterectomy which makes pregnancy impossible.
- •12.Known intolerance or allergy to evolocumab or other PCSK9 inhibitors.
- •13.Currently taking simvastatin >40 mg/day, niacin or bile acid sequestrants
- •14.Known latex allergy
- •15.Inability to comply with protocol-required study visits or procedures, including administration of study drug
- •16.Known history of cancer within the past 5 years (except for carcinoma in- situ of the cervix, stage 1 prostate cancer or adequately treated non-melanoma carcinomas of the skin)
- •17.Participation in another investigational device or drug study which is likely to affect the primary outcome, within 30 days of planned initiation of study drug
- •18.NYHA class IV
- •19.Pacemaker or other implantable device implanted within 30 days prior to screening
研究者
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