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

NCT06818279 | Not Yet Recruiting Phase 2

• 1 other identifier: ILBS-Cirrhosis-72
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Portal Vein Thrombosis; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups.

  6 months

Secondary Outcomes (11)

• Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.

  6 months

• Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.

  6 months

• Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups.

  3 months

• Rate of recurrence of Portal Vein Thrombosis at 12 months.

  12 months

• Adverse events in both the groups till 6-months

  6 months

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

Enoxaparin Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.

Drug: Enoxaparin

Dabigatran

EXPERIMENTAL

Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.

Drug: Dabigatran

Interventions

Dabigatran DRUG

Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.

Dabigatran

Enoxaparin DRUG

Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.

Enoxaparin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.

You may not qualify if:

• Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
• CTP \>10
• Hepatocellular carcinoma
• Tumoral PVT
• Isolated gastric varices with red colour signs
• Peptic ulcer disease with large ulcers
• Pregnant or breastfeeding women
• Thrombocytopenia (platelet count \<50,000/μL)
• Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
• Those not giving consent for therapy

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Dabigatran; Enoxaparin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Dr Sarthak Chanana, MD

CONTACT

01146300000; xs2sarthak@gmail.com

Dr Rajan V, DM

CONTACT

01146300000; rajanvf40@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: January 31, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

IN (1)