Anticoagulation Plus Tocilizumab for Acute Cerebral Venous Thrombosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial compares standard anticoagulant therapy alone versus anticoagulation plus tocilizumab in adults with acute CVT. The aim is to determine if targeting IL-6–mediated inflammation can improve outcomes and safety. Participants are followed during hospitalization and after discharge, with clinical, imaging, and laboratory assessments and monitoring for adverse events. Eligible patients are 18 to 80 years old with imaging-confirmed acute CVT and symptom onset within a defined recent window. Exclusion criteria include recent immunosuppressive therapy, other immune diseases, infectious diseases, significant brain herniation, and severe hepatic impairment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xuanwu Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xunming Ji
• Email: jixm@ccmu.edu.cn
• Phone: 01083198962

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.