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Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis

2026年9月3日 更新者：Ji Xunming,MD,PhD、Capital Medical University
This study aims to evaluate the efficacy and safety of tocilizumab, an interleukin-6 (IL-6) receptor antagonist, combined with standard anticoagulant therapy compared with standard anticoagulant therapy alone in patients with acute cerebral venous thrombosis (CVT).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Background: Inflammation, particularly IL-6-mediated inflammatory responses, may contribute to disease progression and brain injury in acute cerebral venous thrombosis (CVT).

Objective: This study aims to evaluate the efficacy and safety of tocilizumab combined with standard anticoagulant therapy in patients with acute CVT.

Method: This is a prospective, randomized, double-blind, placebo-controlled trial. Eligible patients with acute CVT are randomly assigned to receive standard anticoagulant therapy plus a single intravenous dose of tocilizumab or placebo. Clinical outcomes, laboratory parameters, imaging findings, and adverse events are assessed during hospitalization and follow-up.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100053
        • 招聘中
        • Xuanwu Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Aged 18-80 years.
  2. Acute cerebral venous thrombosis (CVT) confirmed by neuroimaging, including MRI, MRV, CTV, MRBTI, or DSA.
  3. Time from symptom onset to enrollment within 14 ± 14 days.
  4. Written informed consent obtained from the participant.
  5. Ability and willingness to comply with the study protocol and scheduled follow-up visits.

Exclusion Criteria:

  1. Treatment with immunosuppressive agents within 7 days before enrollment.
  2. Isolated cortical vein thrombosis or isolated cavernous sinus thrombosis.
  3. Concomitant immune-related diseases, including Behçet disease or systemic lupus erythematosus.
  4. Concomitant infectious diseases.
  5. Primary or secondary immunodeficiency.
  6. Concomitant hematologic disorders or inherited coagulation abnormalities.
  7. Intracerebral hemorrhage with extension into the ventricular system or subarachnoid space.
  8. Imaging evidence of midline shift >10 mm or cerebral herniation. Moderate or severe hepatic impairment, defined as Child-Pugh class B or C.
  9. Creatinine clearance <30 mL/min.
  10. Severe trauma or major surgery within 2 weeks before enrollment.
  11. Serious comorbid disease that may result in an unfavorable prognosis within 1 year.
  12. Pregnancy, puerperium, or breastfeeding.
  13. Contraindication to anti-IL-6 therapy.
  14. Contraindication to anticoagulant therapy.
  15. Psychiatric illness or inability to cooperate with study-related examinations or treatment.
  16. Known allergy to contrast agents or study medication.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Tocilizumab
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.
药品：Tocilizumab
Tocilizumab 240 mg will be diluted with 0.9% sodium chloride to a total volume of 100 mL and administered as a single intravenous infusion over more than 1 hour.
安慰剂比较：Standard treatment
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
药品：Standard Treatment
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Modified Rankin Scale (mRS) score at 1 month after treatment
大体时间：1 month
The modified Rankin Scale (mRS) score will be assessed at 1 month after treatment. The mRS ranges from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate worse functional outcomes.
1 month

次要结果测量

结果测量
措施说明
大体时间
Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment
大体时间：2 weeks and 3 months
The modified Rankin Scale (mRS) score will be assessed at 2 weeks and 3 months after treatment. The mRS ranges from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate worse functional outcomes.
2 weeks and 3 months
National Institutes of Health Stroke Scale (NIHSS) score at 2 weeks, 1 month, and 3 months after treatment
大体时间：2 weeks, 1 month, and 3 months
The National Institutes of Health Stroke Scale (NIHSS) score will be assessed at 2 weeks, 1 month, and 3 months after treatment. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment.
2 weeks, 1 month, and 3 months
Headache Impact Test-6 (HIT-6) score at 2 weeks, 1 month, and 3 months after treatment
大体时间：2 weeks, 1 month, and 3 months.
The Headache Impact Test-6 (HIT-6) score will be assessed at 2 weeks, 1 month, and 3 months after treatment. The HIT-6 total score ranges from 36 to 78, with higher scores indicating a greater impact of headache on daily functioning.
2 weeks, 1 month, and 3 months.
Intracranial pressure (ICP) at 2 weeks after treatment
大体时间：2 weeks
Intracranial pressure (ICP) will be assessed at 2 weeks after treatment.
2 weeks
Cerebral venous sinus recanalization status assessed by magnetic resonance venography (MRV)
大体时间：3 months
Cerebral venous sinus recanalization status will be evaluated using magnetic resonance venography (MRV) at 3 months after treatment.
3 months
Change in cerebral venous sinus stenosis and thrombus burden assessed by magnetic resonance black-blood thrombus imaging (MRBTI)
大体时间：3 months
Changes in cerebral venous sinus stenosis and thrombus burden will be evaluated using magnetic resonance black-blood thrombus imaging (MRBTI) at 3 months after treatment.
3 months

其他结果措施

结果测量
措施说明
大体时间
Incidence of serious adverse events related to anti-IL-6 treatment
大体时间：Up to 6 months
Serious adverse events considered related to anti-IL-6 treatment will be recorded throughout the study period.
Up to 6 months
Incidence of recurrent cerebral venous thrombosis or other vascular events
大体时间：Up to 6 months
The incidence of recurrent cerebral venous thrombosis or other vascular events will be assessed during follow-up. Other vascular events include venous thromboembolic events occurring during follow-up.
Up to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Capital Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年3月1日

初级完成 (估计的)

2028年9月30日

研究完成 (估计的)

2028年9月30日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年8月30日

首次发布 (实际的)

2026年9月3日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ACTIVE (Nationwide Children's Hospital Intramural Grant - 292913)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The study is proceeding.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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