An interventional study of Tocilizumab and Standard Treatment in Cerebral Venous Thrombosis, sponsored by Capital Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
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).
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.
46 studies on the registry are indexed under Intracranial Thrombosis; 15 are open to participants now.
This study's planned enrollment of 80 is below the median of 140 across 20 interventional studies indexed under Intracranial Thrombosis.
Browse Intracranial Thrombosis studies →Capital Medical University is the lead sponsor of 295 studies on the registry; 91 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.
Drug: Tocilizumab
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
Drug: Standard Treatment
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.
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
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.
Time frame: 1 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
Plan to share: No — The study is proceeding.
No publications or documents are linked to this record.
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Studies of the drug tested here: Tocilizumab