NCT03900026

Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery

A Randomized Trial of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery (NEWTON-CABG)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 782 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Bypass Graft Surgery
• Atherosclerosis
• Vein Occlusion

Interventions

Type	Name	Description
DRUG	Evolocumab	REPATHA (evolocumab) is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); it will be administered via subcutaneous injection
OTHER	Placebo	Placebo cartridges will contain vehicle only; placebo will be administered via subcutaneous injection.

Timeline

• Start date: 2019-05-30
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2019-04-02
• Last updated: 2025-08-29

Locations

22 sites across 4 countries: United States, Australia, Canada, Hungary

Regulatory

• FDA-regulated drug study