Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery
- Conditions
- Vein OcclusionCoronary Artery Bypass Graft SurgeryAtherosclerosis
- Interventions
- Other: Placebo
- Registration Number
- NCT03900026
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 766
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Treatment Placebo Participants will receive subcutaneous injections of the placebo Q2W (every 2 weeks) Evolocumab Treatment Evolocumab Participants will receive subcutaneous injections of 140mg of evolocumab Q2W (every two weeks)
- Primary Outcome Measures
Name Time Method Saphenous vein graft disease rate (VGDR) 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.
- Secondary Outcome Measures
Name Time Method The proportion of patients with at least 1 vein graft totally (100%) occluded. 24 months post CABG Proportion of patients who have at least 1 totally (100%) occluded vein graft at 24 months post CABG.
The percentage of vein grafts which are totally (100%) occluded grafts. 24 months post CABG Percentage of vein grafts that are totally (100%) occluded at 24 months post CABG.
Trial Locations
- Locations (9)
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
🇨🇦Québec, Quebec, Canada
Foothills Medical Centre
🇨🇦Calgary, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Maine Medical Center
🇺🇸Portland, Maine, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States