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Trials
Published in: Trials 1/2008

Open Access 01-12-2008 | Study protocol

Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study)

Authors: David C Crossman, Allison C Morton, Julian P Gunn, John P Greenwood, Alistair S Hall, Keith AA Fox, Andrew J Lucking, Marcus D Flather, Belinda Lees, Claire E Foley

Published in: Trials | Issue 1/2008

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Abstract

Background

Acute Coronary Syndromes account for 15% of deaths in the UK, and patients remain at significant risk of re-admission for future complications and death. Pathologically the underlying process of atherosclerosis is driven by inflammatory mechanisms, which are activated in ACS patients. Previous studies have investigated the role of inflammatory markers in this process, including interleukin 1 (IL-1) and C Reactive Protein (CRP). Pre-clinical studies indicate that IL-1 may be a primary driver of ACS and that the naturally occurring interleukin-1 receptor antagonist (IL-1ra) may inhibit the atherosclerotic process. This study will investigate the effects of IL-1ra on inflammatory markers in man.

Methods/design

Three centres in the UK are planning to recruit 186 Non-ST elevation myocardial infarction patients to receive either interleukin-1 receptor antagonist (Anakinra) or matching placebo. Patients will receive a daily subcutaneous injection of either study drug or placebo over a 14 day period. The primary outcome is area under the curve of high sensitivity C-Reactive Protein (CRP) over the first 7 days.

Discussion

The MRC-ILA-HEART Study is a proof of concept clinical trial investigating the effects of IL-1ra upon markers of inflammation in patients with Non-ST elevation myocardial infarction. It is hoped this will provide new and exciting information in relation to an "anti-inflammatory" strategy for patients with acute coronary syndrome.

Trial registration

ISRCTN89369318
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Metadata
Title
Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study)
Authors
David C Crossman
Allison C Morton
Julian P Gunn
John P Greenwood
Alistair S Hall
Keith AA Fox
Andrew J Lucking
Marcus D Flather
Belinda Lees
Claire E Foley
Publication date
01-12-2008
Publisher
BioMed Central
Published in
Trials / Issue 1/2008
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-9-8

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