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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

Xuehong Chu, Zhengfei Ma, Yifeng Liu, Jun Sun, Ning Wang, Chaoqun Li, Xiangyang Feng, Jianqiao Li, Benxiao Wang, Chen Zhou, Chuanhui Li, Wenbo Zhao, Xunming Ji, Chuanjie Wu
DOI: 10.1136/svn-2024-003574 Published 28 November 2024
Xuehong Chu
1Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China
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Zhengfei Ma
2Department of Neurology, Suzhou Municipal Hospital of Anhui Province, Suzhou, Anhui, China
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Yifeng Liu
3Department of Neurology, Nanyang Central Hospital, Nanyang, Henan, China
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Jun Sun
3Department of Neurology, Nanyang Central Hospital, Nanyang, Henan, China
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Ning Wang
3Department of Neurology, Nanyang Central Hospital, Nanyang, Henan, China
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Chaoqun Li
4Department of Neurology, Xihua County People's Hospital, Zhoukou, Henan, China
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Xiangyang Feng
4Department of Neurology, Xihua County People's Hospital, Zhoukou, Henan, China
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Jianqiao Li
5Department of Neurology, Sui Xi County Hospita, Anhui Province, China
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Benxiao Wang
6Anhui Wanbei Coal Electricity Group General Hospital, Suzhou, China
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Chen Zhou
7Beijing Institute of Brain Disorders, Capital Medical University, Beijing, China
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Chuanhui Li
1Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China
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Wenbo Zhao
1Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China
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Xunming Ji
1Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China
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Chuanjie Wu
1Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China
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    Figure 1

    Study flow chart. AIS, acute ischaemic stroke; EVT, endovascular therapy; ICA, intracranial carotid artery; ICH, intracranial cerebral haemorrhage; M1, first segment of the middle cerebral artery; M2, second segment of the middle cerebral artery; mRS, modified Rankin scale; NIHSS score, National Institute of Health Stroke Scale.

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    Assessment flow chart

    ScreeningFollow-up
    BaselineRandomisationImmediately postoperative24±6 hours48±12 hours72±12 hours7 days±12 hour or at discharge90±7 days
    Inclusion/exclusion criteriax
    Informed consentx
    Randomisationx
    Demographicsx
    Medical historyx
    Previous medicationx
    Vital signsxxxxXx
    Physical examinationx
    Laboratory testsxxxXx
    Prestroke mRSx
    mRSx
    NIHSS scorexxXx
    Brain CT plus CTP/MRIx
    CTA/MRA/DSAxX
    Brain CT/MRIX
    ASPECTSx
    mTICI scorex
    AOL gradeX
    ComedicationxxxXxx
    Barthel indexx
    EQ-5Dx
    AE/SAExxxXxx
    • AE, adverse event; ASPECTS, Alberta Stroke Programme Early CT Score; CTA, CT angiography; CTP, CT perfusion; DSA, digital subtraction angiography; EQ-5D, EuroQol 5 Dimensions Questionnaire; AOL grade, American Society of Interventional and Therapeutic Neuroradiology (ASITN)-Society of Interventional Radiology (SIR) Grading System for Thrombolysis in Acute Ischaemic Stroke; MRA, MR angiography; mRS, modified Rankin scale; mTICI, modified Thrombolysis in Cerebral Infarction; NIHSS, National Institute of Health Stroke Scale; SAE, serious adverse event; TOAST, Trial of Org 10 172 in Acute Stroke Treatment classification.

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    [svn-2024-003574supp001.pdf]

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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
Xuehong Chu, Zhengfei Ma, Yifeng Liu, Jun Sun, Ning Wang, Chaoqun Li, Xiangyang Feng, Jianqiao Li, Benxiao Wang, Chen Zhou, Chuanhui Li, Wenbo Zhao, Xunming Ji, Chuanjie Wu
Stroke and Vascular Neurology Nov 2024, svn-2024-003574; DOI: 10.1136/svn-2024-003574

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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
Xuehong Chu, Zhengfei Ma, Yifeng Liu, Jun Sun, Ning Wang, Chaoqun Li, Xiangyang Feng, Jianqiao Li, Benxiao Wang, Chen Zhou, Chuanhui Li, Wenbo Zhao, Xunming Ji, Chuanjie Wu
Stroke and Vascular Neurology Nov 2024, svn-2024-003574; DOI: 10.1136/svn-2024-003574
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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
Xuehong Chu, Zhengfei Ma, Yifeng Liu, Jun Sun, Ning Wang, Chaoqun Li, Xiangyang Feng, Jianqiao Li, Benxiao Wang, Chen Zhou, Chuanhui Li, Wenbo Zhao, Xunming Ji, Chuanjie Wu
Stroke and Vascular Neurology Nov 2024, svn-2024-003574; DOI: 10.1136/svn-2024-003574
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