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

3. september 2026 oppdatert av: 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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100053
        • Rekruttering
        • Xuanwu Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tocilizumab
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.
Legemiddel: 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.
Legemiddel: Standard Treatment
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Capital Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2025

Primær fullføring (Antatt)

30. september 2028

Studiet fullført (Antatt)

30. september 2028

Datoer for studieregistrering

Først innsendt

24. august 2026

Først innsendt som oppfylte QC-kriteriene

30. august 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The study is proceeding.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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