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

Last updated: July 9, 2020
Sponsor: St. Michael's Hospital, Toronto
Overall Status: Active - Recruiting

Phase

4

Condition

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT03900026
NEWTON CABG (Cardiolink-007)
  • 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, aparticipant 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 60 days

  5. On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily,rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statinor non-statin therapy is clinically justified Exclusion Criteria - A participant will be ineligible for participation in this study if heor she satisfies any one or more of the following criteria:

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

  7. Allergy to contrast dye

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

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

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

  11. Use of cholesterylester transfer protein (CETP) inhibition treatment within 12 monthsprior to randomization.

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

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

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

  15. Women who are pregnant or breastfeeding

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

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

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

  19. Known latex allergy

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

  21. 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)

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

  23. NYHA class IV

  24. 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 to randomization

Study Design

Total Participants: 766
Study Start date:
May 30, 2019
Estimated Completion Date:
December 01, 2023

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

  • University of Alberta

    Edmonton, Alberta T6G 2R8
    Canada

    Active - Recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

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

    Québec, Quebec
    Canada

    Active - Recruiting

  • Foothills Medical Centre

    Calgary,
    Canada

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Active - Recruiting

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