Canakinumab Imaging Sub Study
Research type
Research Study
Full title
A randomised, double-blind,placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post myocardial infarction patients with eleveated hs CRP: An imaging sub study evaluating the effect of canakinumab on carotid atherosclerosis.
IRAS ID
118807
Contact name
Fosca De Iorio
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2012-003010-14
Clinicaltrials.gov Identifier
Research summary
Myocardial infarction (or heart attack) and stroke (blockage or bleed in blood vessels) is mainly caused by blockage of an artery from a build up of fatty material and by chronic inflammation commonly called atherosclerosis. Atherosclerosis is a disease characterized by a high state of inflammation in the blood vessels. Certain inflammatory carriers called interleukins have been shown to be key mediators of this inflammation, in particular interleukin-1β (IL-1β), making it a reasonable target for reducing blood vessel inflammation associated with
atherosclerosis. Canakinumab (ACZ885) is a fully human monoclonal anti-human IL-1β antibody, being developed for the treatment of IL-1β driven inflammatory diseases. High sensitivity C-reactive protein (hs-CRP) is a marker of ongoing inflammation that is readily measured by doing a blood test, and therefore patients with high levels of inflammation after heart attack can readily be identified for this study. In these patients, canakinumab is expected to reduce the risk of future occurrence of major cardiovascular events by preventing further blood vessel inflammation.
The purpose of this sub study is to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months versus placebo on the levles of fatty material that are deposted in the carotid arteries ( in head and neck). The fatty material levels are measured by vascular MRI in N- Approx 30 patients in UK who have provided informed consent for the CACZ885M2301 study(CANTOS). The goal of this imaging sub study is to demonstrate direct evidence of the antherosclerotic effect of canakinumab beyond the lowering of inflammatory biomarkers and also to provide a strong mechanistic link between reduced vascular inflammation via IL-Iβ blockade and the reduction in recurrent ischemic events.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0006
Date of REC Opinion
24 May 2013
REC opinion
Further Information Favourable Opinion