Effektivitet og sikkerhed af interleukin-6-receptor-hæmmer kombineret med endovaskulær behandling hos patienter med akut anterior cirkulations stor karokklusion apopleksi -2 (IRIS-2)
Effektivitet og sikkerhed af interleukin-6-receptorhæmmer kombineret med endovaskulær behandling hos patienter med akut slagtilfælde med stor karokklusion i anterior cirkulation: Et randomiseret, dobbeltblindet, placebokontrolleret klinisk forsøg-2 (IRIS-2)
This study is a randomized, double-blind, placebo-controlled clinical trial. Investigators aim to assess the efficacy and safety of interleukin-6 receptor inhibitor combined with endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days after randomization.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Beijing, Kina, 100053
- Xuanwu Hospital, Capital Medical University
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Beijing, Kina
- Beijing Red Cross Emergency Medical Center
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Shenzhen, Kina
- Shenzhen Longhua District People's Hospital
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Anhui
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Suzhou, Anhui, Kina
- Suzhou Hospital of Anhui Medical University
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Suzhou, Anhui, Kina
- Si Country People's Hospital
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Suzhou, Anhui, Kina
- Suixi County Hospital
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Fujian
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Zhangzhou, Fujian, Kina
- Zhangzhou Municipal Hospital
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Guangxi
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Qinzhou, Guangxi, Kina
- Lingshan County People's Hospital
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Hebei
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Langfang, Hebei, Kina
- JingDong ZhongMei Hospital
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Qinhuangdao, Hebei, Kina
- The second Hospital of Qinhuangdao
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Tangshan, Hebei, Kina
- Tangshan Workers Hospital
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Tangshan, Hebei, Kina
- Yutian Hospital
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Heilongjiang
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Harbin, Heilongjiang, Kina
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Anyang, Henan, Kina
- The People's Hospital of Anyang
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Hebi, Henan, Kina
- Jun County People's Hospital
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Jiaozuo, Henan, Kina
- Jiaozuo No.2 People's Hospital
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Luoyang, Henan, Kina
- Luoyang Central Hospital
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Luoyang, Henan, Kina
- Mengjin County People's Hospital
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Nanyang, Henan, Kina
- Nanyang Central Hospital
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Nanyang, Henan, Kina
- Nanyang Nanshi Hospital
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Nanyang, Henan, Kina
- Tanghe County People's Hospital
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Nanyang, Henan, Kina
- Nanyang Second People's Hospital
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Puyang, Henan, Kina
- Puyang Oilfield General Hospital
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Shangqiu, Henan, Kina
- Shangqiu No.1 People's Hospital
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Shangqiu, Henan, Kina
- Ningling County People's Hospital
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Xinxiang, Henan, Kina
- Xinxiang Central Hospital
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Xinxiang, Henan, Kina
- Huixian People's Hospital
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Xinxiang, Henan, Kina
- The First Affiliated Hospital of Henan Medical University
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Zhengzhou, Henan, Kina
- Henan Provincial People's Hospital
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Zhoukou, Henan, Kina
- Xihua County People's Hospital
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Hubei
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Wuhan, Hubei, Kina
- Tianyou Hospital Affliated to Wuhan University of Science &Technology
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Xiangyang, Hubei, Kina
- Xiangyang No.1 People's hospital
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Inner Mongolia
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Xing’an, Inner Mongolia, Kina
- Xing'an league People's Hospital
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Jiangsu
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Nantong, Jiangsu, Kina
- Nantong First People's Hospital
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Shandong
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Binzhou, Shandong, Kina
- Binzhou Medical University Hospital
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Dongying, Shandong, Kina
- People's Hospital of Dongying
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Linyi, Shandong, Kina
- Linyi People's Hospital
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Linyi, Shandong, Kina
- Linshu Country People's Hospital
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Qingdao, Shandong, Kina
- Qingdao Huangdao District Hospital of Traditional Chinese Medicine
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Zibo, Shandong, Kina
- Zibo Central Hospital
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Zibo, Shandong, Kina
- Yiyuan Country People's Hospital
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Shanxi
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Jincheng, Shanxi, Kina
- Jincheng People's Hospital
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Taiyuan, Shanxi, Kina
- Shanxi Bethune Hospital
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Taiyuan, Shanxi, Kina
- Shanxi Medical University First Hospital
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Xianyang, Shanxi, Kina
- The People's Hospital of Xianyang
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Yulin, Shanxi, Kina
- Daliuta Experimental District People's Hospital of Shenmu City
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Wuhan
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Zhongxiang, Wuhan, Kina
- Zhongxiang Traditional Chinese Medical Hospital
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Zhejiang
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Jiaxing, Zhejiang, Kina
- Jiaxing First Hospital
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Lishui, Zhejiang, Kina
- Lishui Central Hospital
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Ningbo, Zhejiang, Kina
- Ningbo Medical Center Lihuili Hospital
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Ningbo, Zhejiang, Kina
- Ningbo NO.2 Hospital
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Taizhou, Zhejiang, Kina
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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Wenzhou, Zhejiang, Kina
- Wenzhou People's Hospital
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Yueqing, Zhejiang, Kina
- Yueqing People's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18 years or greater, male or female;
- Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1 or proximal/dominant M2 segment;
- Decided to undergo emergency endovascular treatment;
- Time from stroke onset to arterial puncture within 24 hours;
- National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
- Signed informed consent from the patients or the legally authorized representatives.
Exclusion Criteria:
- Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
- Pre-stroke modified Rankin scale (mRS) score >1;
- Known allergy to tocilizumab or excipients;
- Known allergy to iodinated contrast agents;
- Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
- History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, or thrombocytopenic diseases;
- Systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite blood pressure control;
- Neutrophils <2×109 /L;
- Platelets <100×109 /L;
- Blood glucose <2.8mmol/L (50 mg/dL) or >22.2mmol/L (400 mg/dL);
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal;
- Known recent or current serum creatinine >2 times the upper limit of normal or estimated glomerular filtration rate (eGFR) <60 mL/min;
- Pregnant, lactating, or planning pregnancy within 90 days;
- Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia;
- Concurrent malignant tumors or severe systemic diseases with expected survival of less than 90 days;
- Presence of autoimmune diseases or use of immunosuppressive drugs;
- Systemic infectious diseases;
- Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
- Considered by the investigator to have other conditions that might affect compliance or preclude participation in this study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Tocilizumab group
Endovascular treatment combined 240 mg tocilizumab injection once. |
240 mg of tocilizumab injection will be diluted in 0.9% NaCl solution to prepare a total solution volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization, and no later than 30 minutes, with an infusion duration of more than 1 hour. |
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Placebo komparator: Placebo group
Endovascular treatment combined equivalent volume of placebo once. |
An equivalent volume of placebo will be diluted in 0.9% NaCl solution to prepare a total solution volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization, and no later than 30 minutes, with an infusion duration of more than 1 hour. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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modified Rankin Scale (mRS) score at 90 days
Tidsramme: 90 days
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The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
90 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Infarktvolumen efter 24 timer
Tidsramme: 24 timer
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24 timer
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Forekomst af symptomatisk intracerebral blødning inden for 24 timer
Tidsramme: 24 timer
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24 timer
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Forekomsten af enhver intrakraniel blødning inden for 24 timer
Tidsramme: 24 timer
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24 timer
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Andel af patienter med lungebetændelse efter 7 dage eller ved tidlig udskrivning
Tidsramme: 7 dage eller ved tidlig udskrivelse
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7 dage eller ved tidlig udskrivelse
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Proportion of patients with mRS score 0-2 at 90 days
Tidsramme: 90 days and 1year
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90 days and 1year
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Proportion of patients with mRS score 0-1 at 90 days
Tidsramme: 90 days and 1year
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90 days and 1year
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Proportion of Barthel Index (BI) 95-100 at 90 days
Tidsramme: 90 days and 1year
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90 days and 1year
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Mortality at 90 days
Tidsramme: 90 days and 1year
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90 days and 1year
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National Institutes of Health Stroke Scale (NIHSS) score at 7 days or at early discharge
Tidsramme: 7 days or at early discharge
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The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes. |
7 days or at early discharge
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EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days
Tidsramme: 90 days and 1year
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The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scoresindicating worse quality of life. |
90 days and 1year
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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modified Rankin Scale (mRS) score
Tidsramme: 1 year
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The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
1 year
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRIS-2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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