Efficacia e Sicurezza dell'Inibitore del Recettore dell'Interleuchina-6 in Combinazione con il Trattamento Endovascolare in Pazienti con Ictus da Occlusione di Grosso Vaso dell'Anteriore Circolazione -2 (IRIS-2)
Efficacia e Sicurezza dell'Inibitore del Recettore dell'Interleuchina-6 Combinato con Trattamento Endovascolare in Pazienti con Ictus Acuto da Occlusione di Grossi Vasi dell'Anteriore Circolazione: Uno Studio Clinico Randomizzato, in Doppio Cieco, Controllato con Placebo-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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Beijing, Cina, 100053
- Xuanwu Hospital, Capital Medical University
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Beijing, Cina
- Beijing Red Cross Emergency Medical Center
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Shenzhen, Cina
- Shenzhen Longhua District People's Hospital
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Anhui
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Suzhou, Anhui, Cina
- Suzhou Hospital of Anhui Medical University
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Suzhou, Anhui, Cina
- Si Country People's Hospital
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Suzhou, Anhui, Cina
- Suixi County Hospital
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Fujian
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Zhangzhou, Fujian, Cina
- Zhangzhou Municipal Hospital
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Guangxi
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Qinzhou, Guangxi, Cina
- Lingshan County People's Hospital
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Hebei
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Langfang, Hebei, Cina
- JingDong ZhongMei Hospital
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Qinhuangdao, Hebei, Cina
- The second Hospital of Qinhuangdao
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Tangshan, Hebei, Cina
- Tangshan Workers Hospital
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Tangshan, Hebei, Cina
- Yutian Hospital
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Heilongjiang
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Harbin, Heilongjiang, Cina
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Anyang, Henan, Cina
- The People's Hospital of Anyang
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Hebi, Henan, Cina
- Jun County People's Hospital
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Jiaozuo, Henan, Cina
- Jiaozuo No.2 People's Hospital
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Luoyang, Henan, Cina
- Luoyang Central Hospital
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Luoyang, Henan, Cina
- Mengjin County People's Hospital
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Nanyang, Henan, Cina
- Nanyang Central Hospital
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Nanyang, Henan, Cina
- Nanyang Nanshi Hospital
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Nanyang, Henan, Cina
- Tanghe County People's Hospital
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Nanyang, Henan, Cina
- Nanyang Second People's Hospital
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Puyang, Henan, Cina
- Puyang Oilfield General Hospital
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Shangqiu, Henan, Cina
- Shangqiu No.1 People's Hospital
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Shangqiu, Henan, Cina
- Ningling County People's Hospital
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Xinxiang, Henan, Cina
- Xinxiang Central Hospital
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Xinxiang, Henan, Cina
- Huixian People's Hospital
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Xinxiang, Henan, Cina
- The First Affiliated Hospital of Henan Medical University
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Zhengzhou, Henan, Cina
- Henan Provincial People's Hospital
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Zhoukou, Henan, Cina
- Xihua County People's Hospital
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Hubei
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Wuhan, Hubei, Cina
- Tianyou Hospital Affliated to Wuhan University of Science &Technology
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Xiangyang, Hubei, Cina
- Xiangyang No.1 People's hospital
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Inner Mongolia
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Xing’an, Inner Mongolia, Cina
- Xing'an league People's Hospital
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Jiangsu
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Nantong, Jiangsu, Cina
- Nantong First People's Hospital
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Shandong
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Binzhou, Shandong, Cina
- Binzhou Medical University Hospital
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Dongying, Shandong, Cina
- People's Hospital of Dongying
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Linyi, Shandong, Cina
- Linyi People's Hospital
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Linyi, Shandong, Cina
- Linshu Country People's Hospital
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Qingdao, Shandong, Cina
- Qingdao Huangdao District Hospital of Traditional Chinese Medicine
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Zibo, Shandong, Cina
- Zibo Central Hospital
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Zibo, Shandong, Cina
- Yiyuan Country People's Hospital
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Shanxi
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Jincheng, Shanxi, Cina
- Jincheng People's Hospital
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Taiyuan, Shanxi, Cina
- Shanxi Bethune Hospital
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Taiyuan, Shanxi, Cina
- Shanxi Medical University First Hospital
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Xianyang, Shanxi, Cina
- The People's Hospital of Xianyang
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Yulin, Shanxi, Cina
- Daliuta Experimental District People's Hospital of Shenmu City
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Wuhan
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Zhongxiang, Wuhan, Cina
- Zhongxiang Traditional Chinese Medical Hospital
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Zhejiang
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Jiaxing, Zhejiang, Cina
- Jiaxing First Hospital
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Lishui, Zhejiang, Cina
- Lishui Central Hospital
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Ningbo, Zhejiang, Cina
- Ningbo Medical Center Lihuili Hospital
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Ningbo, Zhejiang, Cina
- Ningbo NO.2 Hospital
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Taizhou, Zhejiang, Cina
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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Wenzhou, Zhejiang, Cina
- Wenzhou People's Hospital
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Yueqing, Zhejiang, Cina
- Yueqing People's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore placebo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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modified Rankin Scale (mRS) score at 90 days
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Volume dell'infarto a 24 ore
Lasso di tempo: 24 ore
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24 ore
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Incidenza di emorragia intracerebrale sintomatica entro 24 ore
Lasso di tempo: 24 ore
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24 ore
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Incidenza di qualsiasi emorragia intracerebrale entro 24 ore
Lasso di tempo: 24 ore
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24 ore
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Proporzione di pazienti con polmonite a 7 giorni o alla dimissione precoce
Lasso di tempo: 7 giorni o alla dimissione anticipata
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7 giorni o alla dimissione anticipata
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Proportion of patients with mRS score 0-2 at 90 days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 90 days and 1year
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90 days and 1year
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Mortality at 90 days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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modified Rankin Scale (mRS) score
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRIS-2
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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