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

Phase 4

Active, not recruiting

• Conditions: Vein Occlusion; Coronary Artery Bypass Graft Surgery; Atherosclerosis
• Interventions: Other: Placebo; Drug: Evolocumab

• 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.

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Start: 2019-05-30
• Primary Completion: 2025-01-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-06
• Study Completion: 2025-08-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 782

Inclusion Criteria

Not provided

Exclusion Criteria

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.
Hierarchical composite of the following (each assessed by total wins for each treatment group and the win ratio):	24 months post CABG	1. time to cardiovascular death from baseline to end of study; 2. time to first myocardial infarction from baseline to end of study; 3. time to first coronary revascularization from baseline to end of study; 4. number of vein grafts with 100% stenosis at end of study; 5. number of vein grafts with 50-99% stenosis at end of study; 6. number of occluded arterial grafts at end of study; 7. total plaque volume at end of study; a. time to cardiovascular death from baseline to end of study b. time to first myocardial infarction from baseline to end of study c. time to first coronary revascularization from baseline to end of study d. number of vein grafts with 100% stenosis at end of study e. number of vein grafts with 50-99% stenosis at end of study f. number of occluded arterial grafts at end of study g. total plaque volume at end of study

Trial Locations

Locations (22)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

University Hospital Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, Australia

Monash University; 🇦🇺 Melbourne, Australia

Fiona Stanley Hospital; 🇦🇺 Murdoch, Australia

New Brunswick Heart Centre; 🇨🇦 Saint John's, New Brunswick, Canada

One Heart Care; 🇨🇦 Mississauga, Ontario, Canada

North York Diagnostic and Cardiology Centre; 🇨🇦 North York, Ontario, Canada

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