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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03900026




Registration number
NCT03900026
Ethics application status
Date submitted
28/03/2019
Date registered
2/04/2019
Date last updated
29/08/2025

Titles & IDs
Public title
Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery
Scientific title
A Randomized Trial of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery (NEWTON-CABG)
Secondary ID [1] 0 0
NEWTON CABG (CardioLink-5)
Universal Trial Number (UTN)
Trial acronym
NEWTON-CABG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Bypass Graft Surgery 0 0
Atherosclerosis 0 0
Vein Occlusion 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Evolocumab
Other interventions - Placebo

Placebo comparator: Placebo Treatment - Participants will receive subcutaneous injections of the placebo Q2W (every 2 weeks)

Experimental: Evolocumab Treatment - Participants will receive subcutaneous injections of 140mg of evolocumab Q2W (every two weeks)


Treatment: Drugs: 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 interventions: Placebo
Placebo cartridges will contain vehicle only; placebo will be administered via subcutaneous injection.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Saphenous vein graft disease rate (VGDR)
Timepoint [1] 0 0
24 months post CABG
Secondary outcome [1] 0 0
The proportion of patients with at least 1 vein graft totally (100%) occluded.
Timepoint [1] 0 0
24 months post CABG
Secondary outcome [2] 0 0
The percentage of vein grafts which are totally (100%) occluded grafts.
Timepoint [2] 0 0
24 months post CABG
Secondary outcome [3] 0 0
Hierarchical composite of the following (each assessed by total wins for each treatment group and the win ratio):
Timepoint [3] 0 0
24 months post CABG

Eligibility
Key inclusion criteria
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 without cardiopulmonary 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 statin or non-statin therapy is clinically justified
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 be clinically 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) < 30 mL/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 12 months 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 to reduce 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 or birth control methods to avoid pregnancy. Women are considered post-menopausal and not of childbearing potential after 12 months of natural (spontaneous) amenorrhea or have 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, including administration of study drug
16. Known history of cancer within the past 5 years (except for carcinoma in-situ of the cervix, stage 1 prostate cancer or adequately treated non-melanoma carcinomas of the skin)
17. Participation in another investigational device or drug study which is likely to affect 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

Additional postoperative exclusion criteria:

1. Received only <2 vein grafts
2. Major peri-operative complications following CABG surgery (e.g. stroke, MI, renal failure requiring dialysis, or postoperative ICU stay > 5 days) prior to randomization

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/01/2025
Sample size
Target
Accrual to date
Final
782
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Monash University - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
New Brunswick
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Calgary
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Hungary
State/province [12] 0 0
Zalaegerszeg

Funding & Sponsors
Primary sponsor type
Other
Name
Unity Health Toronto
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Applied Health Research Centre
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Mazer, MD
Address 0 0
Unity Health Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03900026