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The William Harvey Research Institute - Barts and The London

VESALIUS -CV

A double-blind, randomized, placebo-controlled, multicenter study to evaluate the impact of evolocumab on major cardiovascular events in patients at high cardiovascular risk without prior myocardial infarction or stroke.

Trial objective
Reduce the risk of coronary heart disease (CHD) death, myocardial infarction (MI), stroke, and ischemia-driven arterial revascularization in adults at high risk of cardiovascular events without prior MI or stroke.

Disease area
Cardiovascular

Status
Recruitment on hold 

CI/PI
Dr David Collier

Sponsor
AMGEN Limited

Funder
AMGEN Limited

Study summary
Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease and experiencing a cardiovascular event.

The purpose of this global study is to assess whether additional lowering of LDL-C with evolocumab can reduce the risk of major cardiovascular events (i.e., heart attack or stroke) in patients at high cardiovascular risk, when evolocumab is taken in addition to the current lipid lowering medical treatment (i.e., statins) for elevated blood cholesterol levels.

To be eligible, patients should be at high cardiovascular risk for experiencing a major cardiovascular event but without previous heart attack or stroke and must be on stable, optimal lipid-lowering background therapy, as per local guidelines for at least 4 weeks.

Eligible participants will be randomised with an allocation ratio of 1:1 to either receive evolocumab or placebo. Randomised means that participants are put into a group by chance. Through the duration of the study participants will receive bi-weekly treatment with evolocumab or placebo in addition to their current lipid lowering therapy medication. It is estimated that enrolment of participants into this study will take approximately 1 year. Participants will be in this study for a minimum of 4 years or up to about 5 years.

The study will be conducted across numerous hospitals and GP practices across the country as well as in most European countries, Asia, South America and North America.

Sample size and duration
13000 globally, 20 locally for at least 4 years

Enquiries  
Dr David Collier: d.j.collier@qmul.ac.uk
Anne Zak: a.zak@qmul.ac.uk
Patrizia Ebano: p.m.ebano@qmul.ac.uk