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Direct Oral Novel Anticoagulants for Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis

16. mai 2026 oppdatert av: Shanghai Zhongshan Hospital

Multicenter Randomized Controlled Clinical Trial on Direct Oral Novel Anticoagulants for Improving the Prognosis of Cirrhotic Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis

This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours after endoscopic treatment to prevent rebleeding.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

175

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

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:

  • Clinical and imaging diagnosis of liver cirrhosis and esophagogastric varices, with at least one previous episode of esophagogastric variceal bleeding
  • Combined with portal vein thrombosis and D-dimer > 0.8mg/L
  • Endoscopic evaluation reveals a high risk of variceal bleeding, and endoscopic treatment is performed to prevent rebleeding of esophagogastric varices
  • Signed informed consent form

Exclusion Criteria:

  • Received other antithrombotic therapies before (including warfarin, aspirin, low-molecular-weight heparin, etc.)
  • Combined with hepatocellular carcinoma or other malignancy
  • Combined with portal cavernoma
  • Combined with severe life-threatening diseases of circulatory, hematological and respiratory system
  • Combined with diseases requiring anticoagulant therapy, such as acute portal vein thrombosis, atrial fibrillation, lower extremity venous thrombosis, and pulmonary embolism
  • Received TIPS or liver transplantation or splenectomy
  • With contraindications to anticoagulant therapy (uncontrollable active bleeding, severe hepatic insufficiency, renal insufficiency, etc.)
  • Currently taking immunosuppressive agents, or medications that affect cytochrome P450 (including azole antifungals and protease inhibitors), or strong inducers of CYP3A4 (including rifampicin, phenytoin, carbamazepine, etc.)

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: Enkeltgruppeoppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: kontrollgruppe
Eksperimentell: anticoagulant group
Rivaroxaban 10mg qd po. for 6 months
Legemiddel: Rivaroxaban
Rivaroxaban 10mg qd po for 6 months

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adverse events at 6 months
Tidsramme: From enrollment to the end of treatment at 6 months
Within 6 months, the time from randomization to the first occurrence of any of the following events: including gastrointestinal bleeding, new onset or worsening of ascites > grade II, new onset or worsening of portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, and occurrence of death.
From enrollment to the end of treatment at 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adverse events at 1months
Tidsramme: From enrollment to 1months of treatment
Gastrointestinal bleeding, new or aggravated ascites > Grade II, new or aggravated portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, death
From enrollment to 1months of treatment
Adverse events at 2 months
Tidsramme: From enrollment to the 2 months of treatment
Gastrointestinal bleeding, new or aggravated ascites > Grade II, new or aggravated portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, death
From enrollment to the 2 months of treatment
liver function at 6 months of treatment
Tidsramme: From the enrollment to 6 months of treatment
Changes in liver function at 6 months of treatment measured by ALT/AST/Total Bilirubin level
From the enrollment to 6 months of treatment
renal function at 6 months of treatment
Tidsramme: From the enrollment to 6 months of treatment
Changes in renal function at 6 months of treatment measured by serum creatinine level
From the enrollment to 6 months of treatment
Hemodynamic changes at 6 months
Tidsramme: From enrollment to the end of treatment at 6 months
flow velocity of the portal vein system (m/s) measured by ultrasound
From enrollment to the end of treatment at 6 months
Patency of portal vein thrombosis at 6 months
Tidsramme: From enrollment to the end of treatment at 6 months
changes of portal vein thrombosis measured by CT Venography at 6 months (progress or recanalization）
From enrollment to the end of treatment at 6 months
liver stiffness at 6 months
Tidsramme: From enrollment to the end of treatment at 6 months
liver stiffness after 6 months of treatment measured by fibroscan
From enrollment to the end of treatment at 6 months
spleen stiffness at 6 months
Tidsramme: From enrollment to the end of treatment at 6 months
spleen stiffness after 6 months of treatment measured by fibroscan.
From enrollment to the end of treatment at 6 months
Rivaroxaban Plasma Concentration at 6 Months
Tidsramme: From enrollment to the end of treatment at 6 months
Changes in Rivaroxaban Plasma Concentration After 6 Months of Treatment
From enrollment to the end of treatment at 6 months
Serum metabolomics at 6 months
Tidsramme: From enrollment to the end of treatment at 6 months
metabolomic analysis of the patients' serum after treatment for 6 months using Liquid Chromatography-Mass Spectrometry (LC-MS)
From enrollment to the end of treatment at 6 months

Samarbeidspartnere og etterforskere

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

Sponsor

Shanghai Zhongshan Hospital

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 (Antatt)

1. juni 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

25. april 2026

Først innsendt som oppfylte QC-kriteriene

16. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY2026028

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