Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London

About this trial

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.

Eligibility criteria

Qualifiers

Liver cirrhosis secondary to alcohol, with or without associated metabolic risk factors, i.e. Alcohol related liver disease (ARLD) or metabolic dysfunction-associated steatotic liver disease, where there has been a significant history of alcohol consumption (MetALD)

Cirrhosis will be based on histology, or clear radiological evidence, e.g. nodular or heterogeneous liver or non-invasive testing (e.g. Fibroscan®, or Enhanced Liver Fibrosis (ELF) test

Childs A Cirrhosis (Participants with a previous episode of decompensated cirrhosis who have now recompensated can be included)

Participants with no hepatic encephalopathy or low-grade hepatic encephalopathy (Grade 0 or 1) taking lactulose and/or rifaximin

Disqualifiers

Evidence of decompensation (e.g. ascites requiring treatment other than a thin rim around liver on imaging, as above) (Evidence of decompensation as follows: Grade 2 or 3 Ascites, Grade 2 - 4 Hepatic Encephalopathy, Variceal Haemorrhage)

Causes for cirrhosis other than alcohol, including those with MASLD who have never drunk alcohol above government recommended levels (14 units/week)

Pre-existing splanchnic vein thrombosis (portal, splenic, mesenteric, and hepatic veins)

Use of (and need for) anticoagulation or dual antiplatelet therapy or clopidogrel

Trial design

Treatments tested in this trial

  • Apixaban 2.5 mg twice daily
  • Placebo

Treatment groups

1,142 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University College, London

Lead sponsor

Royal Free Hospital NHS Foundation Trust

Collaborator

NHS Greater Glasgow and Clyde

Collaborator

University Hospital of Wales

Collaborator

University of Nottingham

Collaborator

Liverpool University Hospitals NHS Foundation Trust

Collaborator

University Hospital Southampton NHS Foundation Trust

Collaborator

King's College Hospital NHS Trust

Collaborator

King's College London

Collaborator

Hull University Teaching Hospitals NHS Trust

Collaborator

Imperial College London

Collaborator

The Leeds Teaching Hospitals NHS Trust

Collaborator

The Royal London Hospital, UK

Collaborator

BRITISH LIVER TRUST

Collaborator