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

NCT07801638 | Recruiting DMC

• 1 other identifier: ACTIVE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cerebral Venous Thrombosis

Keywords

Interleukin-6 Receptor Inhibitor; Cerebral venous thrombosis; Anticoagulation; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment

  2 weeks and 3 months

• National Institutes of Health Stroke Scale (NIHSS) score at 2 weeks, 1 month, and 3 months after treatment

  2 weeks, 1 month, and 3 months

• Headache Impact Test-6 (HIT-6) score at 2 weeks, 1 month, and 3 months after treatment

  2 weeks, 1 month, and 3 months.

• Intracranial pressure (ICP) at 2 weeks after treatment

  2 weeks

• Cerebral venous sinus recanalization status assessed by magnetic resonance venography (MRV)

  3 months

Other Outcomes (2)

• Incidence of recurrent cerebral venous thrombosis or other vascular events

  Up to 6 months

• Incidence of serious adverse events related to anti-IL-6 treatment

  Up to 6 months

Study Arms (2)

Tocilizumab

EXPERIMENTAL

Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.

Drug: Tocilizumab

Standard treatment

PLACEBO COMPARATOR

Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.

Drug: Standard Treatment

Interventions

Tocilizumab DRUG

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.

Tocilizumab

Standard Treatment DRUG

Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.

Standard treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Intracranial Thrombosis; Inflammation

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xunming Ji

CONTACT

01083198962; jixm@ccmu.edu.cn

Chen Zhou

CONTACT

chenzhou2013abc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 3, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)