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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization; for approximately a median of 4.5 years
Awards & highlights

VESALIUS-CV 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.Check my eligibility
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.See study design
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.

VESALIUS-CV Trial 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.

VESALIUS-CV Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Time to All Cause of Death
Time to Any Ischemia-driven Arterial Revascularization
Time to CHD Death
+7 more

Side effects data

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

VESALIUS-CV 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
1,380 Previous Clinical Trials
1,367,320 Total Patients Enrolled
MDStudy DirectorAmgen
925 Previous Clinical Trials
914,343 Total Patients Enrolled

Media Library

Evolocumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03872401 — Phase 3
Coronary Heart Disease Research Study Groups: Placebo, Evolocumab 140 mg Q2W
Coronary 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
Coronary Heart Disease Patient Testimony for trial: Trial Name: NCT03872401 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be eligible to participate in this experiment?

"Myocardial ischemia patients that are between 50 and 79 years old may qualify for this trial. Right now, the study is looking to enroll around 12,301 people."

Answered by AI

Is this study seeking patients that are 25 years or older?

"This research is looking for individuals that fall between 50-79 years old."

Answered by AI

How many people total are receiving treatment as part of this experiment?

"This study is not looking for new patients at this moment. The trial was first posted on June 11th, 2019 and last updated December 3rd, 2021. There are presently 1104 other clinical trials actively enrolling patients with myocardial ischemia and 23 studies relating to Evolocumab which are still recruiting participants."

Answered by AI

What are physicians concerned about when prescribing Evolocumab?

"There is already some data supporting Evolocumab's efficacy and safety, as this drug has been studied in Phase 3 clinical trials."

Answered by AI

What does the Evolocumab clinical trial data tell us about other potential treatments?

"Evolocumab was first trialled in 2018 by the Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley. There are now 18,310 completed studies and 23 trials that are still recruiting patients. Many of these active trials are located in Miami and New york City."

Answered by AI

Can you give me an estimate for how many different places this trial is running?

"Patients can enrol at Gad Research Center in Miami, New york, Northwell Health Physician Partners in Southampton, Ontario, Heart Health Institute in Ajax, Indiana or one of the 100 other locations."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
New York
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
What site did they apply to?
Arkansas Cardiology
Jacksonville Center for Clinical Research
Brigham and Womens Hospital
Other

What questions have other patients asked about this trial?

How often are screening appointments scheduled?
PatientReceived no prior treatments

Why did patients apply to this trial?

Just looking at potential options to help with h. To improve my cholesterol, and increase my stamina.
PatientReceived 1 prior treatment
My brother died of heart problems and they have affected my other brother and mothers life and health.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
2019. "Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03872401.
All > Coronary Artery Disease > Paid Studies Maine
~2359 spots leftby Jul 2025
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