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

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).

Study Overview

• Status: Recruiting
• Conditions: Cerebral Venous Thrombosis
• Intervention / Treatment: Drug: Tocilizumab; Drug: Standard Treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Chen Zhou; Email: chenzhou2013abc@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Xuanwu Hospital
      • Contact: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tocilizumab; Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.	Drug: 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.
Placebo Comparator: Standard treatment; Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.	Drug: Standard Treatment; Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS) score at 1 month after treatment	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment	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	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	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	Intracranial pressure (ICP) will be assessed at 2 weeks after treatment.	2 weeks
Cerebral venous sinus recanalization status assessed by magnetic resonance venography (MRV)	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events related to anti-IL-6 treatment	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	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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 30, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Anticoagulation; Cerebral venous thrombosis; Interleukin-6 Receptor Inhibitor
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Embolism and Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Pathological Conditions, Signs and Symptoms; Inflammation; Intracranial Thrombosis; tocilizumab
• Other Study ID Numbers: ACTIVE (Nationwide Children's Hospital Intramural Grant - 292913)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study is proceeding.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No