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Monoclonal Antibodies

Evolocumab for Heart Disease (VESALIUS-CV Trial)

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria
Evidence of at least one of the following at screening (without prior myocardial infarction or stroke): A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus
Must not have
Last measured left-ventricular ejection fraction ˂ 30% or New York Heart Association (NYHA) Functional Class III/IV
Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization; for approximately a median of 4.5 years
Awards & highlights
Pivotal Trial

Summary

This trial will see if evolocumab, a cholesterol-lowering drug, can prevent major cardiovascular events in high-risk adults who have not had a heart attack or stroke.

Who is the study for?
This trial is for adults aged 50-80 without a history of heart attack or stroke but at high risk for cardiovascular events. They must have high levels of LDL-C or other lipid markers and evidence of significant coronary, cerebrovascular, peripheral arterial disease, or diabetes with at least one high-risk feature.
What is being tested?
The study tests the effect of Evolocumab on preventing major cardiovascular events compared to a placebo in individuals with no prior myocardial infarction or stroke but who are considered at high risk due to their cholesterol levels.
What are the potential side effects?
Evolocumab may cause side effects like injection site reactions, cold-like symptoms, back pain, and allergic reactions. It's generally well-tolerated but can rarely lead to more serious issues like muscle problems and immune-mediated conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man over 50 or a woman over 55, but under 80, and meet the cholesterol guidelines.
Select...
I have significant heart, brain, or leg artery disease, or diabetes.
Select...
A. You have a serious heart artery disease. B. You have a serious blood vessel disease in your brain. C. You have a serious blood vessel disease in your arms or legs. D. You have diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart's pumping ability is very weak.
Select...
I have frequent, uncontrolled heartbeats without a device to correct it.
Select...
I am scheduled for a procedure to restore blood flow in my arteries.
Select...
I have atrial fibrillation or flutter and am not on blood thinners.
Select...
I have had a heart attack or stroke before being assigned to a treatment group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization; for approximately a median of 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization; for approximately a median of 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Coronary Heart Disease Death, Myocardial Infarction, Ischemic Stroke, or Any Ischemia-driven Arterial Sroke
Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Evolocumab 140 mg Q2WExperimental Treatment1 Intervention
Participants will receive 140 mg evolocumab by subcutaneous injection Q2W.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
2011
Completed Phase 4
~13010

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,433 Previous Clinical Trials
1,382,841 Total Patients Enrolled
MDStudy DirectorAmgen
971 Previous Clinical Trials
927,013 Total Patients Enrolled

Media Library

Evolocumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03872401 — Phase 3
Heart disease Research Study Groups: Placebo, Evolocumab 140 mg Q2W
Heart disease Clinical Trial 2023: Evolocumab Highlights & Side Effects. Trial Name: NCT03872401 — Phase 3
Evolocumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03872401 — Phase 3
Heart disease Patient Testimony for trial: Trial Name: NCT03872401 — Phase 3
~1348 spots leftby Jul 2025
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