APEACH

• Research type

  Research Study

• Full title

  APEACH: Apixaban to Prevent dEcompensation of eArly liver CirrHosis trial

• IRAS ID

  1013519

• Contact name

  James Blackstone

• Contact email

  j.blackstone@ucl.ac.uk

• Sponsor organisation

  Comprehensive Clinical Trials Unit at UCL

• ISRCTN Number

  ISRCTN11391276

• Research 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 lead 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 poor quality of life, often need to go to hospital and on average only live for 2 more years.
  The APEACH trial will investigate if giving compensated cirrhosis patients Apixaban will help stop them 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.
  1142 people with cirrhosis due to alcohol will be recruited from about 55 hospitals. Participants will be randomly allocated to receive Apixaban or an identical looking placebo. Neither patients nor doctors will know which is which, a double-blind trial. Participants will take the tablets for a minimum of 12 months up to 4 years and will be followed up every 6 months in line with standard liver clinic appointments. They will be assessed for decompensated cirrhosis and unwanted side-effects. The major possible side-effect is bleeding, especially from the stomach. Patients will be informed to watch for this & to contact the team with any concerns. If a participant decompensates, they will stop taking trial treatment.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  26/YH/0102

• Date of REC Opinion

  8 Jun 2026

• REC opinion

  Further Information Favourable Opinion