[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654612":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":57,"studyPopulation":48,"armGroups":58,"interventions":71,"overallOfficials":48,"centralContacts":79,"locations":88,"responsibleParty":105,"collaborators":48,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":48,"eligibilityCriteria":114,"healthyVolunteers":111,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":48,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":91,"whyStopped":48,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Capital Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,26,30,34],{"measure":15,"description":16,"timeFrame":17},"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.","2 weeks and 3 months",{"measure":19,"description":20,"timeFrame":21},"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.","2 weeks, 1 month, and 3 months",{"measure":23,"description":24,"timeFrame":25},"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.","2 weeks, 1 month, and 3 months.",{"measure":27,"description":28,"timeFrame":29},"Intracranial pressure (ICP) at 2 weeks after treatment","Intracranial pressure (ICP) will be assessed at 2 weeks after treatment.","2 weeks",{"measure":31,"description":32,"timeFrame":33},"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.","3 months",{"measure":35,"description":36,"timeFrame":33},"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.",[38,42],{"measure":39,"description":40,"timeFrame":41},"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.","Up to 6 months",{"measure":43,"description":44,"timeFrame":41},"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.",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":48,"timePerspective":48,"maskingInfo":50},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":51,"maskingDescription":48,"whoMasked":52},"QUADRUPLE",[53,54,55,56],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Background: Inflammation, particularly IL-6-mediated inflammatory responses, may contribute to disease progression and brain injury in acute cerebral venous thrombosis (CVT).\n\nObjective: This study aims to evaluate the efficacy and safety of tocilizumab combined with standard anticoagulant therapy in patients with acute CVT.\n\nMethod: 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.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Tocilizumab","EXPERIMENTAL","Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.",[64],"Drug: Tocilizumab",{"label":66,"type":67,"description":68,"interventionNames":69},"Standard treatment","PLACEBO_COMPARATOR","Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.",[70],"Drug: Standard Treatment",[72,76],{"type":73,"name":60,"description":74,"armGroupLabels":75,"otherNames":48},"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.",[60],{"type":73,"name":77,"description":68,"armGroupLabels":78,"otherNames":48},"Standard Treatment",[66],[80,85],{"name":81,"role":82,"phone":83,"phoneExt":48,"email":84},"Xunming Ji","CONTACT","01083198962","jixm@ccmu.edu.cn",{"name":86,"role":82,"phone":48,"phoneExt":48,"email":87},"Chen Zhou","chenzhou2013abc@163.com",[89],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Xuanwu Hospital","RECRUITING","Beijing","Beijing Municipality","100053","China","CN",{"type":98,"coordinates":99},"Point",[100,101],116.39723,39.9075,{"lat":101,"lon":100},[104],{"name":81,"role":82,"phone":83,"phoneExt":48,"email":84},{"type":106,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"PRINCIPAL_INVESTIGATOR","Ji Xunming,MD,PhD","Professor of Neurology, Xuanwu Hospital, Capital Medical University","100654612","anticoagulation-combined-with-tocilizumab-for-interleukin-6-receptor-inhibition-in-acute-cerebral-venous-thrombosis-100654612",false,"NCT07801638","Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis","Inclusion Criteria:\n\n1. Aged 18-80 years.\n2. Acute cerebral venous thrombosis (CVT) confirmed by neuroimaging, including MRI, MRV, CTV, MRBTI, or DSA.\n3. Time from symptom onset to enrollment within 14 ± 14 days.\n4. Written informed consent obtained from the participant.\n5. Ability and willingness to comply with the study protocol and scheduled follow-up visits.\n\nExclusion Criteria:\n\n1. Treatment with immunosuppressive agents within 7 days before enrollment.\n2. Isolated cortical vein thrombosis or isolated cavernous sinus thrombosis.\n3. Concomitant immune-related diseases, including Behçet disease or systemic lupus erythematosus.\n4. Concomitant infectious diseases.\n5. Primary or secondary immunodeficiency.\n6. Concomitant hematologic disorders or inherited coagulation abnormalities.\n7. Intracerebral hemorrhage with extension into the ventricular system or subarachnoid space.\n8. Imaging evidence of midline shift \\>10 mm or cerebral herniation. Moderate or severe hepatic impairment, defined as Child-Pugh class B or C.\n9. Creatinine clearance \\\u003C30 mL\u002Fmin.\n10. Severe trauma or major surgery within 2 weeks before enrollment.\n11. Serious comorbid disease that may result in an unfavorable prognosis within 1 year.\n12. Pregnancy, puerperium, or breastfeeding.\n13. Contraindication to anti-IL-6 therapy.\n14. Contraindication to anticoagulant therapy.\n15. Psychiatric illness or inability to cooperate with study-related examinations or treatment.\n16. Known allergy to contrast agents or study medication.","ALL","18 Years","80 Years",{"count":119,"type":120},80,"ESTIMATED","INTERVENTIONAL",[123],"NA","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).",[126],"Cerebral Venous Thrombosis",[128,129,130,131],"Interleukin-6 Receptor Inhibitor","Cerebral venous thrombosis","Anticoagulation","Inflammation","2026-09-03",{"date":134,"type":135},"2026-09-09","ACTUAL",{"date":137,"type":135},"2025-03-01",{"date":139,"type":120},"2028-09-30",{"name":5,"class":6},1]