Evolocumab for Heart Disease
(VESALIUS-CV Trial)
Recruiting at 859 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Amgen
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.
Research Team
M
MD
Principal Investigator
Amgen
Eligibility Criteria
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.Inclusion Criteria
I am a man over 50 or a woman over 55, but under 80, and meet the cholesterol guidelines.
I have significant heart, brain, or leg artery disease, or diabetes.
You have at least one significant risk factor.
See 2 more
Exclusion Criteria
Your triglyceride levels are higher than 500 mg/dL in the past 3 months.
I have not had a heart bypass surgery in the last 3 months.
My heart's pumping ability is very weak.
See 5 more
Treatment Details
Interventions
- Evolocumab (Monoclonal Antibodies)
- Placebo (Other)
Trial OverviewThe 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.
Participant Groups
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London