Efficacité et sécurité de l'inhibiteur du récepteur de l'interleukine-6 combiné au traitement endovasculaire chez les patients atteints d'accident vasculaire cérébral aigu par occlusion de gros vaisseaux du territoire antérieur -2 (IRIS-2)
Efficacité et sécurité de l'inhibiteur du récepteur de l'interleukine-6 combiné à un traitement endovasculaire chez les patients victimes d'un accident vasculaire cérébral par occlusion de gros vaisseaux de la circulation antérieure : un essai clinique randomisé, en double aveugle, contrôlé par 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Beijing, Chine, 100053
- Xuanwu Hospital, Capital Medical University
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Beijing, Chine
- Beijing Red Cross Emergency Medical Center
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Shenzhen, Chine
- Shenzhen Longhua District People's Hospital
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Anhui
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Suzhou, Anhui, Chine
- Suzhou Hospital of Anhui Medical University
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Suzhou, Anhui, Chine
- Si Country People's Hospital
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Suzhou, Anhui, Chine
- Suixi County Hospital
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Fujian
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Zhangzhou, Fujian, Chine
- Zhangzhou Municipal Hospital
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Guangxi
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Qinzhou, Guangxi, Chine
- Lingshan County People's Hospital
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Hebei
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Langfang, Hebei, Chine
- JingDong ZhongMei Hospital
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Qinhuangdao, Hebei, Chine
- The second Hospital of Qinhuangdao
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Tangshan, Hebei, Chine
- Tangshan Workers Hospital
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Tangshan, Hebei, Chine
- Yutian Hospital
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Heilongjiang
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Harbin, Heilongjiang, Chine
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Anyang, Henan, Chine
- The People's Hospital of Anyang
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Hebi, Henan, Chine
- Jun County People's Hospital
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Jiaozuo, Henan, Chine
- Jiaozuo No.2 People's Hospital
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Luoyang, Henan, Chine
- Luoyang Central Hospital
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Luoyang, Henan, Chine
- Mengjin County People's Hospital
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Nanyang, Henan, Chine
- Nanyang Central Hospital
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Nanyang, Henan, Chine
- Nanyang Nanshi Hospital
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Nanyang, Henan, Chine
- Tanghe County People's Hospital
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Nanyang, Henan, Chine
- Nanyang Second People's Hospital
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Puyang, Henan, Chine
- Puyang Oilfield General Hospital
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Shangqiu, Henan, Chine
- Shangqiu No.1 People's Hospital
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Shangqiu, Henan, Chine
- Ningling County People's Hospital
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Xinxiang, Henan, Chine
- Xinxiang Central Hospital
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Xinxiang, Henan, Chine
- Huixian People's Hospital
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Xinxiang, Henan, Chine
- The First Affiliated Hospital of Henan Medical University
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Zhengzhou, Henan, Chine
- Henan Provincial People's Hospital
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Zhoukou, Henan, Chine
- Xihua County People's Hospital
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Hubei
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Wuhan, Hubei, Chine
- Tianyou Hospital Affliated to Wuhan University of Science &Technology
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Xiangyang, Hubei, Chine
- Xiangyang No.1 People's hospital
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Inner Mongolia
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Xing’an, Inner Mongolia, Chine
- Xing'an league People's Hospital
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Jiangsu
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Nantong, Jiangsu, Chine
- Nantong First People's Hospital
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Shandong
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Binzhou, Shandong, Chine
- Binzhou Medical University Hospital
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Dongying, Shandong, Chine
- People's Hospital of Dongying
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Linyi, Shandong, Chine
- Linyi People's Hospital
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Linyi, Shandong, Chine
- Linshu Country People's Hospital
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Qingdao, Shandong, Chine
- Qingdao Huangdao District Hospital of Traditional Chinese Medicine
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Zibo, Shandong, Chine
- Zibo Central Hospital
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Zibo, Shandong, Chine
- Yiyuan Country People's Hospital
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Shanxi
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Jincheng, Shanxi, Chine
- Jincheng People's Hospital
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Taiyuan, Shanxi, Chine
- Shanxi Bethune Hospital
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Taiyuan, Shanxi, Chine
- Shanxi Medical University First Hospital
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Xianyang, Shanxi, Chine
- The People's Hospital of Xianyang
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Yulin, Shanxi, Chine
- Daliuta Experimental District People's Hospital of Shenmu City
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Wuhan
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Zhongxiang, Wuhan, Chine
- Zhongxiang Traditional Chinese Medical Hospital
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Zhejiang
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Jiaxing, Zhejiang, Chine
- Jiaxing First Hospital
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Lishui, Zhejiang, Chine
- Lishui Central Hospital
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Ningbo, Zhejiang, Chine
- Ningbo Medical Center Lihuili Hospital
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Ningbo, Zhejiang, Chine
- Ningbo NO.2 Hospital
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Taizhou, Zhejiang, Chine
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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Wenzhou, Zhejiang, Chine
- Wenzhou People's Hospital
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Yueqing, Zhejiang, Chine
- Yueqing People's Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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modified Rankin Scale (mRS) score at 90 days
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Volume de l'infarctus à 24 heures
Délai: 24 heures
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24 heures
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Incidence d'hémorragie intracérébrale symptomatique dans les 24 heures
Délai: 24 heures
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24 heures
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Incidence de toute hémorragie intracérébrale dans les 24 heures
Délai: 24 heures
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24 heures
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Proportion de patients atteints de pneumonie à 7 jours ou lors d'une sortie précoce
Délai: 7 jours ou à la sortie précoce
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7 jours ou à la sortie précoce
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Proportion of patients with mRS score 0-2 at 90 days
Délai: 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
Délai: 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
Délai: 90 days and 1year
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90 days and 1year
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Mortality at 90 days
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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modified Rankin Scale (mRS) score
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRIS-2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Informations sur les médicaments et les dispositifs, documents d'étude
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