Cerebral Venous ThrombosisNCT07801638
Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis
A study testing Tocilizumab and Standard Treatment in people with Cerebral Venous Thrombosis, run by Capital Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- Tocilizumab and Standard Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chen Zhou contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Xunming Ji, 01083198962, jixm@ccmu.edu.cn
About this study
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).
Read the 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.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- Tocilizumab, Standard Treatment
- Keywords
- Interleukin-6 Receptor Inhibitor, Cerebral venous thrombosis, Anticoagulation, Inflammation
- Medical subject headings
- Intracranial Thrombosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab. Receives: Drug: Tocilizumab |
| Standard treatment | Placebo comparator | Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo. Receives: Drug: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Mar 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801638
- Sponsor's protocol ID
- ACTIVE
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is proceeding.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis
- ClinicalTrials.gov ID
- NCT07801638
- Acronym / sponsor ID
- ACTIVE
- Conditions
- Cerebral Venous Thrombosis
- Keywords
- Interleukin-6 Receptor Inhibitor, Cerebral venous thrombosis, Anticoagulation, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: TocilizumabParticipants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab. |
| Standard treatment | Placebo comparator | Drug: Standard TreatmentParticipants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabTocilizumab 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. | Drug | Tocilizumab |
| Standard TreatmentParticipants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo. | Drug | Standard treatment |
Primary outcome
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.
6 secondary outcomes
Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment
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
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
Time frame: 2 weeks, 1 month, and 3 months.
Intracranial pressure (ICP) at 2 weeks after treatment
Time frame: 2 weeks
Cerebral venous sinus recanalization status assessed by magnetic resonance venography (MRV)
Time frame: 3 months
Change in cerebral venous sinus stenosis and thrombus burden assessed by magnetic resonance black-blood thrombus imaging (MRBTI)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. The study is proceeding.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen Zhou contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocilizumab and Standard Treatment in people with Cerebral Venous Thrombosis, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) score at 1 month after treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.