drugset / Trial / NCT06818279

Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis

NCT06818279

Phase 2/3 Not yet recruiting 120 enrolled Institute of Liver and Biliary Sciences, India
RandomizedParallel-groupOpen-labelTreatment

Summary

Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.

Timeline

Start
2025-01-31
Primary completion
2026-01-31
Completion
2026-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran Unknown 150 mg
Comparator Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous