A Randomized Trial of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery (NEWTON-CABG)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 782
- 试验地点
- 22
- 主要终点
- Saphenous vein graft disease rate (VGDR)
研究概览
简要总结
The purpose of this study is to determine if evolocumab added to regular statin therapy improves vein graft patency after coronary artery bypass graft (CABG) surgery.
详细描述
Coronary artery bypass graft (CABG) surgery is a procedure in which an artery or vein from the body is grafted to a critically narrowed coronary artery to restore flow of oxygenated blood to the heart. Statins are frequently prescribed after CABG surgery in order to lower LDL cholesterol levels and reduce the chances of coronary artery obstruction recurring. Despite this preventive measure, new vein grafts do end up becoming blocked in a significant proportion of patients. Evolocumab (Repatha®) is a recently approved medication that has been shown to effectively lower LDL cholesterol levels in the blood.
NEWTON-CABG is an investigator-initiated multicenter, double-blind, randomized, placebo-controlled, parallel group study of evolocumab [140mg administered subcutaneously (SC) every two weeks (Q2W)] added to statin therapy for 24 months postoperatively in a broad population of patients undergoing CABG surgery. Eligible subjects will be randomized to receive evolocumab or placebo within 21 days of index CABG. Prior to randomization, post-operative patients will be on moderate or high intensity statin therapy (atorvastatin 40-80mg, rosuvastatin 20-40mg or simvastatin 40mg daily unless another statin/dose or non-statin alternative is clinically justified). A CTAngiogram will be conducted at 24 months following CABG. Routine study visits will be done 3, 6, 12, 18 and 24 months post-surgery.
This study is supported by Amgen Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo Treatment
Participants will receive subcutaneous injections of the placebo Q2W (every 2 weeks)
干预措施: Placebo (Other)
Evolocumab Treatment
Participants will receive subcutaneous injections of 140mg of evolocumab Q2W (every two weeks)
干预措施: Evolocumab (Drug)
结局指标
主要结局
Saphenous vein graft disease rate (VGDR)
时间窗: 24 months post CABG
Saphenous vein graft disease rate (VGDR) is defined as the proportion of vein grafts with significant stenosis or total occlusion (≥50%) on 64-slice (or greater) cardiac CT angiography (CTA) or clinically indicated coronary angiography.
次要结局
- The proportion of patients with at least 1 vein graft totally (100%) occluded.(24 months post CABG)
- The percentage of vein grafts which are totally (100%) occluded grafts.(24 months post CABG)
- Hierarchical composite of the following (each assessed by total wins for each treatment group and the win ratio):(24 months post CABG)