Effectiviteit en Veiligheid van Interleukine-6-Receptorremmer Gecombineerd met Endovasculaire Behandeling bij Patiënten met Acuut Anterior Cirkulatie Groot Vaatocclusie Beroerte -2 (IRIS-2)
Effectiviteit en veiligheid van interleukine-6-receptorremmer gecombineerd met endovasculaire behandeling bij patiënten met acute grote vatocclusie in de voorste circulatie: een gerandomiseerde, dubbelblinde, placebo-gecontroleerde klinische studie-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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Beijing, China, 100053
- Xuanwu Hospital, Capital Medical University
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Beijing, China
- Beijing Red Cross Emergency Medical Center
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Shenzhen, China
- Shenzhen Longhua District People's Hospital
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Anhui
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Suzhou, Anhui, China
- Suzhou Hospital of Anhui Medical University
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Suzhou, Anhui, China
- Si Country People's Hospital
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Suzhou, Anhui, China
- Suixi County Hospital
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Fujian
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Zhangzhou, Fujian, China
- Zhangzhou Municipal Hospital
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Guangxi
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Qinzhou, Guangxi, China
- Lingshan County People's Hospital
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Hebei
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Langfang, Hebei, China
- JingDong ZhongMei Hospital
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Qinhuangdao, Hebei, China
- The second Hospital of Qinhuangdao
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Tangshan, Hebei, China
- Tangshan Workers Hospital
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Tangshan, Hebei, China
- Yutian Hospital
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Heilongjiang
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Harbin, Heilongjiang, China
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Anyang, Henan, China
- The People's Hospital of Anyang
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Hebi, Henan, China
- Jun County People's Hospital
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Jiaozuo, Henan, China
- Jiaozuo No.2 People's Hospital
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Luoyang, Henan, China
- Luoyang Central Hospital
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Luoyang, Henan, China
- Mengjin County People's Hospital
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Nanyang, Henan, China
- Nanyang Central Hospital
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Nanyang, Henan, China
- Nanyang Nanshi Hospital
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Nanyang, Henan, China
- Tanghe County People's Hospital
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Nanyang, Henan, China
- Nanyang Second People's Hospital
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Puyang, Henan, China
- Puyang Oilfield General Hospital
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Shangqiu, Henan, China
- Shangqiu No.1 People's Hospital
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Shangqiu, Henan, China
- Ningling County People's Hospital
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Xinxiang, Henan, China
- Xinxiang Central Hospital
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Xinxiang, Henan, China
- Huixian People's Hospital
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Xinxiang, Henan, China
- The First Affiliated Hospital of Henan Medical University
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Zhengzhou, Henan, China
- Henan Provincial People's Hospital
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Zhoukou, Henan, China
- Xihua County People's Hospital
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Hubei
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Wuhan, Hubei, China
- Tianyou Hospital Affliated to Wuhan University of Science &Technology
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Xiangyang, Hubei, China
- Xiangyang No.1 People's hospital
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Inner Mongolia
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Xing’an, Inner Mongolia, China
- Xing'an league People's Hospital
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Jiangsu
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Nantong, Jiangsu, China
- Nantong First People's Hospital
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Shandong
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Binzhou, Shandong, China
- Binzhou Medical University Hospital
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Dongying, Shandong, China
- People's Hospital of Dongying
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Linyi, Shandong, China
- Linyi People's Hospital
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Linyi, Shandong, China
- Linshu Country People's Hospital
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Qingdao, Shandong, China
- Qingdao Huangdao District Hospital of Traditional Chinese Medicine
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Zibo, Shandong, China
- Zibo Central Hospital
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Zibo, Shandong, China
- Yiyuan Country People's Hospital
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Shanxi
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Jincheng, Shanxi, China
- Jincheng People's Hospital
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Taiyuan, Shanxi, China
- Shanxi Bethune Hospital
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Taiyuan, Shanxi, China
- Shanxi Medical University First Hospital
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Xianyang, Shanxi, China
- The People's Hospital of Xianyang
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Yulin, Shanxi, China
- Daliuta Experimental District People's Hospital of Shenmu City
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Wuhan
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Zhongxiang, Wuhan, China
- Zhongxiang Traditional Chinese Medical Hospital
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Zhejiang
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Jiaxing, Zhejiang, China
- Jiaxing First Hospital
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Lishui, Zhejiang, China
- Lishui Central Hospital
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Ningbo, Zhejiang, China
- Ningbo Medical Center Lihuili Hospital
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Ningbo, Zhejiang, China
- Ningbo NO.2 Hospital
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Taizhou, Zhejiang, China
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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Wenzhou, Zhejiang, China
- Wenzhou People's Hospital
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Yueqing, Zhejiang, China
- Yueqing People's Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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-vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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modified Rankin Scale (mRS) score at 90 days
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Infarctvolume na 24 uur
Tijdsspanne: 24 uur
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24 uur
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Incidentie van symptomatische intracerebrale bloeding binnen 24 uur
Tijdsspanne: 24 uur
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24 uur
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Incidentie van intracerebrale bloeding binnen 24 uur
Tijdsspanne: 24 uur
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24 uur
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Aandeel patiënten met longontsteking na 7 dagen of bij vroege ontslag
Tijdsspanne: 7 dagen of bij vroege ontslag
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7 dagen of bij vroege ontslag
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Proportion of patients with mRS score 0-2 at 90 days
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 90 days and 1year
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90 days and 1year
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Mortality at 90 days
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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modified Rankin Scale (mRS) score
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRIS-2
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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