急性前大循環領域大血管閉塞性脳卒中患者におけるインターロイキン-6受容体阻害薬と血管内治療の併用の有効性と安全性-2 (IRIS-2)
急性前大循環領域大血管閉塞性脳卒中患者におけるインターロイキン-6受容体阻害薬と血管内治療の併用の有効性と安全性：無作為化二重盲検プラセボ対照臨床試験-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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Beijing、中国、100053
- Xuanwu Hospital, Capital Medical University
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Beijing、中国
- Beijing Red Cross Emergency Medical Center
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Shenzhen、中国
- Shenzhen Longhua District People's Hospital
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Anhui
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Suzhou、Anhui、中国
- Suzhou Hospital of Anhui Medical University
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Suzhou、Anhui、中国
- Si Country People's Hospital
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Suzhou、Anhui、中国
- Suixi County Hospital
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Fujian
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Zhangzhou、Fujian、中国
- Zhangzhou Municipal Hospital
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Guangxi
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Qinzhou、Guangxi、中国
- Lingshan County People's Hospital
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Hebei
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Langfang、Hebei、中国
- JingDong ZhongMei Hospital
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Qinhuangdao、Hebei、中国
- The second Hospital of Qinhuangdao
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Tangshan、Hebei、中国
- Tangshan Workers Hospital
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Tangshan、Hebei、中国
- Yutian Hospital
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Heilongjiang
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Harbin、Heilongjiang、中国
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Anyang、Henan、中国
- The People's Hospital of Anyang
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Hebi、Henan、中国
- Jun County People's Hospital
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Jiaozuo、Henan、中国
- Jiaozuo No.2 People's Hospital
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Luoyang、Henan、中国
- Luoyang Central Hospital
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Luoyang、Henan、中国
- Mengjin County People's Hospital
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Nanyang、Henan、中国
- Nanyang Central Hospital
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Nanyang、Henan、中国
- Nanyang Nanshi Hospital
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Nanyang、Henan、中国
- Tanghe County People's Hospital
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Nanyang、Henan、中国
- Nanyang Second People's Hospital
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Puyang、Henan、中国
- Puyang Oilfield General Hospital
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Shangqiu、Henan、中国
- Shangqiu No.1 People's Hospital
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Shangqiu、Henan、中国
- Ningling County People's Hospital
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Xinxiang、Henan、中国
- Xinxiang Central Hospital
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Xinxiang、Henan、中国
- Huixian People's Hospital
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Xinxiang、Henan、中国
- The First Affiliated Hospital of Henan Medical University
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Zhengzhou、Henan、中国
- Henan Provincial People's Hospital
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Zhoukou、Henan、中国
- Xihua County People's Hospital
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Hubei
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Wuhan、Hubei、中国
- Tianyou Hospital Affliated to Wuhan University of Science &Technology
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Xiangyang、Hubei、中国
- Xiangyang No.1 People's hospital
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Inner Mongolia
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Xing’an、Inner Mongolia、中国
- Xing'an league People's Hospital
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Jiangsu
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Nantong、Jiangsu、中国
- Nantong First People's Hospital
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Shandong
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Binzhou、Shandong、中国
- Binzhou Medical University Hospital
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Dongying、Shandong、中国
- People's Hospital of Dongying
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Linyi、Shandong、中国
- Linyi People's Hospital
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Linyi、Shandong、中国
- Linshu Country People's Hospital
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Qingdao、Shandong、中国
- Qingdao Huangdao District Hospital of Traditional Chinese Medicine
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Zibo、Shandong、中国
- Zibo Central Hospital
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Zibo、Shandong、中国
- Yiyuan Country People's Hospital
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Shanxi
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Jincheng、Shanxi、中国
- Jincheng People's Hospital
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Taiyuan、Shanxi、中国
- Shanxi Bethune Hospital
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Taiyuan、Shanxi、中国
- Shanxi Medical University First Hospital
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Xianyang、Shanxi、中国
- The People's Hospital of Xianyang
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Yulin、Shanxi、中国
- Daliuta Experimental District People's Hospital of Shenmu City
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Wuhan
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Zhongxiang、Wuhan、中国
- Zhongxiang Traditional Chinese Medical Hospital
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Zhejiang
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Jiaxing、Zhejiang、中国
- Jiaxing First Hospital
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Lishui、Zhejiang、中国
- Lishui Central Hospital
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Ningbo、Zhejiang、中国
- Ningbo Medical Center Lihuili Hospital
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Ningbo、Zhejiang、中国
- Ningbo NO.2 Hospital
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Taizhou、Zhejiang、中国
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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Wenzhou、Zhejiang、中国
- Wenzhou People's Hospital
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Yueqing、Zhejiang、中国
- Yueqing People's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
modified Rankin Scale (mRS) score at 90 days
時間枠：90 days
|
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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24時間後の梗塞容積
時間枠：24時間
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24時間
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24時間以内の症状性頭蓋内出血の発生率
時間枠：24時間
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24時間
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24時間以内のあらゆる脳内出血の発生率
時間枠：24時間
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24時間
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7日時点または早期退院時点での肺炎患者の割合
時間枠：7日間または早期退院時
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7日間または早期退院時
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Proportion of patients with mRS score 0-2 at 90 days
時間枠：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
時間枠：90 days and 1year
|
90 days and 1year
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Proportion of Barthel Index (BI) 95-100 at 90 days
時間枠：90 days and 1year
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90 days and 1year
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Mortality at 90 days
時間枠：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
時間枠：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
時間枠：90 days and 1year
|
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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
modified Rankin Scale (mRS) score
時間枠：1 year
|
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
1 year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IRIS-2
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。