Introduction Interleukin-6 (IL-6) may be involved in ischaemia-reperfusion injury and myocardial remodelling after myocardial infarction (MI). We have recently shown that IL-6 inhibition by tocilizumab attenuates systemic inflammation and troponin T-release in patients with acute non-ST elevation MI (NSTEMI). Experimental studies suggest that IL-6 inhibition can limit infarct size through anti-inflammatory mechanisms, but this has not been tested in clinical studies. With the ASSessing the effect of Anti-IL-6 treatment in MI (ASSAIL-MI) trial, we aim to examine whether a single administration of the IL-6 receptor antagonist tocilizumab can increase myocardial salvage in patients with acute ST-elevation MI (STEMI).
Methods and analysis The ASSAIL-MI trial is a randomised, double blind, placebo-controlled trial, conducted at three high-volume percutaneous coronary intervention (PCI) centres in Norway. 200 patients with first-time STEMI presenting within 6 hours of the onset of chest pain will be randomised to receive tocilizumab or matching placebo prior to PCI. The patients are followed-up for 6 months. The primary endpoint is the myocardial salvage index measured by cardiac MRI (CMR) 3–7 days after the intervention. Secondary endpoints include final infarct size measured by CMR and plasma markers of myocardial necrosis. Efficacy and safety assessments during follow-up include blood sampling, echocardiography and CMR.
Ethics and dissemination Based on previous experience the study is considered feasible and safe. If tocilizumab increases myocardial salvage, further endpoint-driven multicentre trials may be initiated. The ASSAIL-MI trial has the potential to change clinical practice in patients with STEMI.
Registration Clinicaltrials.gov, identifier NCT03004703.
- coronary artery disease
- Myocardial Ischaemia and Infarction (IHD)
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Funding The ASSAIL-MI trial is an investigator-initiated study supported by unrestricted grants provided by the South-Eastern Norway Regional Health Authority. F.Hoffmann-La Roche Ltd, Grenacherstrasse 124, 4070 Basel, Switzerland has provided the investigational medicinal product used in this trial and has also provided an unrestricted sum for the implementation of the study. The funding sources have no role in the design of the study; neither will they participate in the implementation of the trial, in the analyses of the results, or in the decision to publish. The investigators take sole responsibility for the integrity of the data, the writing of the manuscript and the dissemination of the results.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Regional Committee for Medical and Health Research Ethics of South-Eastern Norway and the Norwegian Medicines Agency.
Provenance and peer review Not commissioned; internally peer reviewed.
Data availability statement Data are available in a public, open access repository.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.