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 objectiveReduce 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 areaCardiovascular
StatusRecruitment on hold
CI/PIDr David Collier
SponsorAMGEN Limited
FunderAMGEN Limited
Study summaryElevated 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 duration13000 globally, 20 locally for at least 4 years
Enquiries Dr David Collier: d.j.collier@qmul.ac.ukAnne Zak: a.zak@qmul.ac.ukPatrizia Ebano: p.m.ebano@qmul.ac.uk