A Phase 3 interventional study of Apixaban 2.5 mg twice daily and Placebo in Liver Cirrhosis, sponsored by University College, London. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by University College, London · Phase 3, Interventional, and Prevention
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 1,142 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinical evidence of portal hypertension, defined as any 1 of:
Or Platelet count \< 150,000 μL AND any 1 of:
Exclusion Criteria:
Participants randomised to receive a matching placebo
Drug: Placebo
Drug: Apixaban 2.5 mg twice daily
Participants randomised to this arm will receive Apixaban 2.5mg twice daily
Placebo will be given as oral tablet and taken twice daily
Time from randomisation to first decompensation event, assessed up to 49 months
First decompensation event is defined as at least one of the following: Grade 2 or 3 ascites according to the International Club of Ascites (ICA), or spontaneous bacterial peritonitis; Grade 2-4 hepatic encephalopathy; variceal haemorrhage (gastrointestinal bleeding secondary to rupture of varices); and liver-related death measured using METHOD at 6-monthly trial follow-up visits and throughout the trial, when location study teams become aware of these events, as decompensation normally involves hospitalisation
Time frame: Time from randomisation to first decompensation event, assessed up to 49 months
Time from randomisation to first decompensation event, assessed up to 49 months
Time to event for individual decompensation events measured at 6-monthly follow-up visits, assessed up to 49 months
Time frame: Time from randomisation to first decompensation event, assessed up to 49 months
Time to development of grade 1 (small volume) ascites
Small volume ascites
Time frame: Time from randomisation assessed up to 49 months
Assessment of safety of anticoagulation in Childs A cirrhosis patients
Assessment of safety of anticoagulation in Childs A cirrhosis patients, including incidence of clinically relevant combined major bleeding and non-major bleeding during trial treatment period
Time frame: Time from randomisation assessed up to 49 months
Time to all-cause mortality
Time frame: Time from randomisation assessed up to 49 months
Time to portal vein thrombosis or other thromboembolic events
Time frame: Time from randomisation assessed up to 49 months
Incidence of cardiac events
Time frame: Time from randomisation assessed up to 49 months
Alcohol use
Alcohol use will be determined by patient reporting on AUDIT-C questionnaire
Time frame: Time from baseline assessed up to 49 months
Health-related quality of life assessed using EQ-5D-5L questionnaire
Time frame: Time from randomisation assessed up to 49 months
Changes in FibroScan® liver stiffness measurement values, splenic elastography, and ELF values as an exploratory outcome
This will be performed in scan performed and technology available
Time frame: Time from baseline assessed up to 49 months
Progression or requirement for TIPSS or transplant as an exploratory outcome
Time frame: Time from randomisation assessed up to 49 months
Time to diagnosis of hepatocellular carcinoma
Time frame: Time from randomisation assessed up to 49 months
Disease progression, comparing changes in MELD and scores between beginning and end of trial
Time frame: Time from randomisation assessed up to 49 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University College, London