Atherosclerosis Clinical Trial
Official title:
A Randomized Trial of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery (NEWTON-CABG)
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.
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.
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