Study of the Impact of Evolocumab on Major Cardiovascular Events
Research type
Research Study
Full title
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
IRAS ID
260824
Contact name
Naveed Sattar
Contact email
Eudract number
2018-004565-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 10 months, 30 days
Research 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.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0152
Date of REC Opinion
11 Jun 2019
REC opinion
Further Information Favourable Opinion