Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

16. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

175

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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:

  • 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

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: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: kontrolgruppe
Eksperimentel: anticoagulant group
Rivaroxaban 10mg qd po. for 6 months
Medicin: Rivaroxaban
Rivaroxaban 10mg qd po for 6 months

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Shanghai Zhongshan Hospital

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 (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

25. april 2026

Først indsendt, der opfyldte QC-kriterier

16. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY2026028

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Privacy policy

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner