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Monoclonal Antibodies

Evolocumab for Coronary Artery Bypass Surgery (NEWTON-CABG Trial)

Phase 4
Waitlist Available
Led By David Mazer, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post cabg
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

This trial will test whether evolocumab, when added to statin therapy, can improve the health of veins used in bypass surgery.

Eligible Conditions
  • Atherosclerosis
  • Coronary Artery Bypass Surgery
  • Venous Occlusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post cabg
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post cabg for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Saphenous vein graft disease rate (VGDR)
Secondary study objectives
The percentage of vein grafts which are totally (100%) occluded grafts.
The proportion of patients with at least 1 vein graft totally (100%) occluded.
Other study objectives
Composite rate of fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, cardiovascular death, coronary heart disease death, repeat coronary revascularization
Percentage of patients free of vein graft disease at 24 months.
Rate of all-cause mortality.
+7 more

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPR - Evolocumab
NPR - Placebo
HPR - Evolocumab
HPR - Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Evolocumab TreatmentExperimental Treatment1 Intervention
Participants will receive subcutaneous injections of 140mg of evolocumab Q2W (every two weeks)
Group II: Placebo TreatmentPlacebo Group1 Intervention
Participants will receive subcutaneous injections of the placebo Q2W (every 2 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
FDA approved

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
562 Previous Clinical Trials
453,185 Total Patients Enrolled
2 Trials studying Atherosclerosis
223 Patients Enrolled for Atherosclerosis
Applied Health Research CentreOTHER
22 Previous Clinical Trials
70,130 Total Patients Enrolled
David Mazer, MDPrincipal InvestigatorUnity Health Toronto
10 Previous Clinical Trials
7,502 Total Patients Enrolled
1 Trials studying Atherosclerosis
100 Patients Enrolled for Atherosclerosis
Subodh Verma, MDPrincipal InvestigatorUnity Health Toronto
6 Previous Clinical Trials
3,255 Total Patients Enrolled
1 Trials studying Atherosclerosis
40 Patients Enrolled for Atherosclerosis
Lawrence Leiter, MDStudy ChairUnity Health Toronto
1 Previous Clinical Trials
2,500 Total Patients Enrolled

Media Library

Evolocumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03900026 — Phase 4
Atherosclerosis Research Study Groups: Evolocumab Treatment, Placebo Treatment
Atherosclerosis Clinical Trial 2023: Evolocumab Highlights & Side Effects. Trial Name: NCT03900026 — Phase 4
Evolocumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900026 — Phase 4
~118 spots leftby Dec 2025