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NCT Number: NCT07801638

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Known allergy to contrast agents or study medication.

Treatment and study plan

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.

standard treatment

Drug

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

Primary outcomes

  1. Modified Rankin Scale (mRS) score at 1 month after treatment

    Time frame: 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.

Secondary outcomes

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

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

    Time frame: 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.

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

    Time frame: 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.

  4. Intracranial pressure (ICP) at 2 weeks after treatment

    Time frame: 2 weeks

    Intracranial pressure (ICP) will be assessed at 2 weeks after treatment.

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

    Time frame: 3 months

    Cerebral venous sinus recanalization status will be evaluated using magnetic resonance venography (MRV) at 3 months after treatment.

  6. Change in cerebral venous sinus stenosis and thrombus burden assessed by magnetic resonance black-blood thrombus imaging (MRBTI)

    Time frame: 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.

Other outcomes

  1. Incidence of recurrent cerebral venous thrombosis or other vascular events

    Time frame: 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.

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

    Time frame: Up to 6 months

    Serious adverse events considered related to anti-IL-6 treatment will be recorded throughout the study period.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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