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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post cabg
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post cabg
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 moreSide effects data
From 2020 Phase 4 trial • 259 Patients • NCT030962885%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- It's not suitable for you to take evolocumab to further lower your LDL cholesterol.You are allergic to the dye used for medical imaging tests.You have severe liver problems.You are allergic to evolocumab or other similar medications.You have a serious heart or other health condition that is likely to make your life expectancy less than 2 years.You are planning to have heart surgery to fix blocked arteries or repair or replace heart valves.You have had or are planning to have a specific type of heart surgery using veins from your leg.You are currently taking, have taken in the past year, or plan to take PCSK9 inhibition treatment.You are currently taking more than 40mg of simvastatin per day, niacin, or bile acid sequestrants.You have had a major organ transplant, such as lung, liver, heart, or bone marrow.You have a serious infection or a major health problem with your blood, kidneys, lungs, metabolism, digestion, or hormones.You had cancer in the last 5 years, except for certain types of early-stage or treated skin and prostate cancers.You have severe heart failure.You have had fewer than 2 vein grafts.You had heart bypass surgery in the last three weeks, or you're going to have it in the next two months.You have taken a certain kind of medication to lower cholesterol within the last year.You had serious complications after heart bypass surgery before joining the study.You are taking a strong cholesterol-lowering medicine, unless your doctor says a different dose or type of medicine is better for you.You have kidney disease with a low estimated glomerular filtration rate (eGFR).
Research Study Groups:
This trial has the following groups:- Group 1: Evolocumab Treatment
- Group 2: Placebo Treatment
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.