CANTOS:CACZ885M2301 Canakinumab in postMI patients with raised hsCRP
Research type
Research Study
Full title
A randomized, 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 elevated hsCRP
IRAS ID
92727
Contact name
Marcus Denis Flather
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2010-022970-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CCRN 738, NIHR adoption number
Duration of Study in the UK
4 years, 6 months, 9 days
Research summary
Myocardial infarction (or heart attack) is mainly caused by blockage of a coronary artery from a build up of fatty material and inflammatory cells called atherosclerosis. Atherosclerosis is a disease characterized by a high state of inflammation in the blood vessels.
Certain inflammatory mediators 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.
Atherosclerosis is the primary cause of illness and death in individuals with and without type 2 diabetes mellitus (T2DM). Heart attack, stroke and blood vessel disease occur at higher frequency in T2DM patients and continue to increase despite use of current optimal therapies such as glucose-lowering, lipid-lowering, blood pressure lowering, and anti-clotting therapies.
Canakinumab is expected to prevent new onset T2DM in patients with a recent past heart attack and who are at risk of developing T2DM. No comparative anti-inflammatory treatment is yet prescribed in patients with cardiovascular disease, and therefore the study is placebo-controlled on top of standard therapies, without an active comparator arm.
The study duration for each participant will be up to approximately 6 years including 2 injections just below the skin at each visit (randomisation, Wk 2, Wk 12 then quarterly).
About 200 patients will be randomised in the UK from approximately 26 sites.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
12/EM/0018
Date of REC Opinion
15 Feb 2012
REC opinion
Further Information Favourable Opinion