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

Last updated: August 22, 2025
Sponsor: Unity Health Toronto
Overall Status: Completed

Phase

4

Condition

Atherosclerosis

Treatment

Evolocumab

Placebo

Clinical Study ID

NCT03900026
NEWTON CABG (CardioLink-5)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria - To be considered eligible for participation in this study, a participant must satisfy each of the following criteria:

  1. Age ≥ 18 years

  2. Scheduled to undergo coronary artery bypass graft (CABG) surgery (with or withoutcardiopulmonary bypass (CPB); with or without single valve repair/replacement)

  3. CABG procedure included/planned to include at least two saphenous vein grafts

  4. CABG procedure occurred within the past 21 days, or is planned within the next 60days

  5. On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mgdaily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, oranother statin or non-statin therapy is clinically justified

Exclusion Criteria - A participant will be ineligible for participation in this study if he or she satisfies any one or more of the following criteria:

  1. Patients in whom additional lowering of LDL-C with evolocumab is deemed to beclinically inappropriate

  2. Allergy to contrast dye

  3. Known severe hepatic impairment (Childs-Pugh, Class C).

  4. Known renal disease with estimated glomerular filtration rate (eGFR) < 30mL/min/1.73m2

  5. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow)

  6. Use of cholesterylester transfer protein (CETP) inhibition treatment within 12months prior to randomization.

  7. Current, prior within past year, or known planned use of PCSK9 inhibition treatment

  8. Severe cardiovascular or concomitant non-cardiovascular disease that is expected toreduce life expectancy to less than 2 years

  9. Major active infection, or major hematologic, renal, respiratory, metabolic,gastrointestinal or endocrine dysfunction

  10. Women who are pregnant or breastfeeding

  11. Women of child bearing potential who are unwilling to use proper family planning orbirth control methods to avoid pregnancy. Women are considered post-menopausal andnot of childbearing potential after 12 months of natural (spontaneous) amenorrhea orhave had a surgical procedure such as hysterectomy which makes pregnancy impossible.

  12. Known intolerance or allergy to evolocumab or other PCSK9 inhibitors.

  13. Currently taking simvastatin >40mg/day, niacin or bile acid sequestrants

  14. Known latex allergy

  15. Inability to comply with protocol-required study visits or procedures, includingadministration of study drug

  16. Known history of cancer within the past 5 years (except for carcinoma in-situ of thecervix, stage 1 prostate cancer or adequately treated non-melanoma carcinomas of theskin)

  17. Participation in another investigational device or drug study which is likely toaffect the primary outcome, within 30 days of planned initiation of study drug

  18. NYHA class IV

  19. Pacemaker or other implantable device implanted within 30 days prior to screening

Exclusion

Additional postoperative exclusion criteria:

  1. Received only <2 vein grafts

  2. Major peri-operative complications following CABG surgery (e.g. stroke, MI, renalfailure requiring dialysis, or postoperative ICU stay > 5 days) prior torandomization

Study Design

Total Participants: 782
Treatment Group(s): 2
Primary Treatment: Evolocumab
Phase: 4
Study Start date:
May 30, 2019
Estimated Completion Date:
January 30, 2025

Study 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.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide 2078025,
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park,
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park 2076918,
    Australia

    Site Not Available

  • Monash University

    Melbourne,
    Australia

    Site Not Available

  • Monash University

    Melbourne 2158177,
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch,
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch 8349091,
    Australia

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2R8
    Canada

    Site Not Available

  • University of Alberta

    Edmonton 5946768, Alberta 5883102 T6G 2R8
    Canada

    Site Not Available

  • New Brunswick Heart Centre

    Saint John's, New Brunswick 6087430
    Canada

    Site Not Available

  • Hamilton Health Sciences

    Hamilton, Ontario
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • One Heart Care

    Mississauga, Ontario
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Hamilton Health Sciences

    Hamilton 5969782, Ontario 6093943
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston 5992500, Ontario 6093943 K7L 2V7
    Canada

    Site Not Available

  • One Heart Care

    Mississauga 6075357, Ontario 6093943
    Canada

    Site Not Available

  • North York Diagnostic and Cardiology Centre

    North York, Ontario 6093943
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Center

    North York, Ontario 6093943
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto 6167865, Ontario 6093943 M5B 1W8
    Canada

    Site Not Available

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    Québec, Quebec
    Canada

    Site Not Available

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    Québec 6325494, Quebec 6115047
    Canada

    Site Not Available

  • Foothills Medical Centre

    Calgary,
    Canada

    Site Not Available

  • Foothills Medical Centre

    Calgary 5913490,
    Canada

    Site Not Available

  • Medical Centre Hungarian Defence Forces

    Budapest,
    Hungary

    Site Not Available

  • Semmelweis University Heart and Vascular Centre

    Budapest,
    Hungary

    Site Not Available

  • Medical Centre Hungarian Defence Forces

    Budapest 3054643,
    Hungary

    Site Not Available

  • Semmelweis University Heart and Vascular Centre

    Budapest 3054643,
    Hungary

    Site Not Available

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg,
    Hungary

    Site Not Available

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg 3042638,
    Hungary

    Site Not Available

  • San Francisco VA Medical Center

    San Francisco, California 94121
    United States

    Site Not Available

  • San Francisco VA Medical Center

    San Francisco 5391959, California 5332921 94121
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Maine Medical Center

    Portland 4975802, Maine 4971068 04102
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Site Not Available

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospital Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

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