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Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis

3. september 2026 opdateret af: Ji Xunming,MD,PhD, Capital Medical University
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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100053
        • Rekruttering
        • Xuanwu Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tocilizumab
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.
Medicin: Tocilizumab
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.
Placebo komparator: Standard treatment
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
Medicin: Standard Treatment
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Rankin Scale (mRS) score at 1 month after treatment
Tidsramme: 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.
1 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment
Tidsramme: 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 weeks and 3 months
National Institutes of Health Stroke Scale (NIHSS) score at 2 weeks, 1 month, and 3 months after treatment
Tidsramme: 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.
2 weeks, 1 month, and 3 months
Headache Impact Test-6 (HIT-6) score at 2 weeks, 1 month, and 3 months after treatment
Tidsramme: 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.
2 weeks, 1 month, and 3 months.
Intracranial pressure (ICP) at 2 weeks after treatment
Tidsramme: 2 weeks
Intracranial pressure (ICP) will be assessed at 2 weeks after treatment.
2 weeks
Cerebral venous sinus recanalization status assessed by magnetic resonance venography (MRV)
Tidsramme: 3 months
Cerebral venous sinus recanalization status will be evaluated using magnetic resonance venography (MRV) at 3 months after treatment.
3 months
Change in cerebral venous sinus stenosis and thrombus burden assessed by magnetic resonance black-blood thrombus imaging (MRBTI)
Tidsramme: 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.
3 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of serious adverse events related to anti-IL-6 treatment
Tidsramme: Up to 6 months
Serious adverse events considered related to anti-IL-6 treatment will be recorded throughout the study period.
Up to 6 months
Incidence of recurrent cerebral venous thrombosis or other vascular events
Tidsramme: 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.
Up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Capital Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2025

Primær færdiggørelse (Anslået)

30. september 2028

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

24. august 2026

Først indsendt, der opfyldte QC-kriterier

30. august 2026

Først opslået (Faktiske)

3. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACTIVE (Nationwide Children's Hospital Intramural Grant - 292913)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The study is proceeding.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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