RT Journal Article
SR Electronic
T1 IRIS, a randomised, double-blind, placebo-controlled trial of interleukin-6 receptor inhibition undergoing endovascular treatment in acute anterior circulation ischaemic stroke: study rationale and design
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP svn-2024-003574
DO 10.1136/svn-2024-003574
A1 Chu, Xuehong
A1 Ma, Zhengfei
A1 Liu, Yifeng
A1 Sun, Jun
A1 Wang, Ning
A1 Li, Chaoqun
A1 Feng, Xiangyang
A1 Li, Jianqiao
A1 Wang, Benxiao
A1 Zhou, Chen
A1 Li, Chuanhui
A1 Zhao, Wenbo
A1 Ji, Xunming
A1 Wu, Chuanjie
YR 2024
UL http://svn.bmj.com/content/early/2024/11/26/svn-2024-003574.abstract
AB Rationale Neuroprotective strategies based on reperfusion therapy hold substantial promise for acute ischaemic stroke (AIS). Preclinical research indicates that tocilizumab, an interleukin-6 receptor antagonist, can attenuate ischaemia-reperfusion damage by exerting anti-inflammatory and neuroprotective effects.Aim To determine tocilizumab’s efficacy and safety when combined with endovascular thrombectomy (EVT) in patients with acute anterior circulation large vessel occlusion (LVO).Sample size estimates To determine a 30% decrease in average infarct core volume comparing the intervention and historical control groups (mean increase of 18.7 mL (SD=9.7 mL) post-thrombectomy) via a two-sided test (alpha=0.05, power=80%), accounting for a 10% drop-out rate, we plan to recruit 108 participants.Methods and design This trial is designed as a randomised, multicentre, double-blind, placebo-controlled trial. Patients will be randomly and evenly allocated to the tocilizumab or placebo groups.Study outcomes The primary endpoint is the change in infarct core volume between baseline and 72 hours post-treatment. Secondary outcomes include the 90-day modified Rankin scale score (0–2, indicating functional independence). The key safety endpoints include 90-day mortality and symptomatic intracerebral haemorrhage within 72 hours after EVT.Discussion Administering tocilizumab within 24 hours of stroke as an adjunct to EVT may effectively reduce the infarct core volume for patients experiencing AIS with anterior circulation LVO, potentially improving functional outcomes in these patients.Data are available on reasonable request. Data access requests should be submitted to the corresponding author and will be subject to review by the study team.