Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial

Summary

Liver disease is the only common cause of death that is increasing in numbers. Once people develop severe scarring (cirrhosis), there are no medications proven to help them live longer, healthier lives. Apixaban is already commonly used to prevent or treat blood clots and is known to be safe for those with cirrhosis.

In the early stages of cirrhosis, most people have no symptoms and lead normal lives; this is called "compensated" cirrhosis. However, when the liver stops working properly, they develop "decompensated" cirrhosis, which causes yellow skin, confusion, vomiting of blood and painful fluid build-up. This is serious, and people are extremely unwell with a poor quality of life, often need to go to the hospital and on average only live for 2 more years.

The APEACH trial will investigate whether giving compensated cirrhosis patients Apixaban will help stop them from developing decompensated cirrhosis and stay in good health for longer.

Previous research studies suggest that taking blood-thinning drugs is safe and helpful for cirrhosis. However, these did not have enough participants to be confident enough in the results to recommend use in everyday clinical care.

The APEACH trial will include enough participants to make it clear whether Apixaban is helpful or not.

Conditions

• Liver Cirrhosis

Interventions

DRUG

Apixaban 2.5 mg twice daily

Participants randomised to this arm will receive Apixaban 2.5mg twice daily

DRUG

Placebo

Placebo will be given as oral tablet and taken twice daily

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• University Hospital of Wales

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• King's College London

  collaborator OTHER

• Hull University Teaching Hospitals NHS Trust

  collaborator OTHER_GOV

• Imperial College London

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• The Royal London Hospital, UK

  collaborator UNKNOWN

• BRITISH LIVER TRUST

  collaborator UNKNOWN

• University College, London

  lead OTHER

Principal Investigators

• Alastair O'Brien · Queen Mary University of London

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-15

Primary Completion

2030-10-31

Completion

2031-03-30