Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial

NCT07726693 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: CCTU 2023-4741013519
• Study Type: interventional
• Target: 1,142
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Liver Cirrhosis; Alcohol Related Liver Disease (ARLD); Metabolic dysfunction-associated steatotic liver disease; Apixaban; MetALD

Outcome Measures

Primary Outcomes (1)

• 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 from randomisation to first decompensation event, assessed up to 49 months

Secondary Outcomes (8)

• 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 development of grade 1 (small volume) ascites

  Time from randomisation assessed up to 49 months

• Assessment of safety of anticoagulation in Childs A cirrhosis patients

  Time from randomisation assessed up to 49 months

• Time to all-cause mortality

  Time from randomisation assessed up to 49 months

• Time to portal vein thrombosis or other thromboembolic events

  Time from randomisation assessed up to 49 months

Other Outcomes (4)

• Changes in FibroScan® liver stiffness measurement values, splenic elastography, and ELF values as an exploratory outcome

  Time from baseline assessed up to 49 months

• Progression or requirement for TIPSS or transplant as an exploratory outcome

  Time from randomisation assessed up to 49 months

• Time to diagnosis of hepatocellular carcinoma

  Time from randomisation assessed up to 49 months

Study Arms (2)

Participants randomised to receive Apixaban 2.5mg oral tablet twice daily

PLACEBO COMPARATOR

Participants randomised to receive a matching placebo

Drug: Placebo

Participants randomised to receive Apixaban 2.5mg twice daily

EXPERIMENTAL

Drug: Apixaban 2.5 mg twice daily

Interventions

Placebo DRUG

Placebo will be given as oral tablet and taken twice daily

Participants randomised to receive Apixaban 2.5mg oral tablet twice daily

Apixaban 2.5 mg twice daily DRUG

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

Participants randomised to receive Apixaban 2.5mg twice daily

Eligibility Criteria

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

You may qualify if:

• 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
• Aged ≥18 years
• Clinical evidence of portal hypertension, defined as any 1 of:
• Evidence of abdominal collateral circulation, recanalised umbilical vein or varices on imaging
• Asymptomatic ascites (trace only) seen around the liver on imaging in patients who are not taking diuretics
• Liver stiffness measurement \>20kPa on FibroScan®/ Vibration- Controlled Transient Elastography (VCTE) (where BMI \<35)
• Presence of Gastro-oesophageal varices at endoscopy
• Hepatic venous pressure gradient ≥ 10mmHg
• Or Platelet count \< 150,000 μL AND any 1 of:
• Spleen size \>13 cm in length
• Liver stiffness measurement \>20kPa on FibroScan®/VCTE (where BMI \>35)
• Presence of portal hypertensive gastropathy at endoscopy

You may not qualify if:

• 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
• Platelets \<50x109/L at screening
• Moderate-severe renal impairment defined as eGFR \<30ml/min at screening
• Recent variceal bleed or untreated large varices
• Malignancy in last 2 years if unlikely to survive trial because of comorbidity in the location PI's opinion
• Hepatocellular carcinoma
• Severe cardiac failure1 or Chronic Obstructive Pulmonary Disease (COPD)
• Pregnancy
• INR \>1.7 (After vitamin K correction) at screening
• Previous hypersensitivity reaction to Apixaban

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• University College, London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• University Hospital of Wales: collaborator
• University of Nottingham: 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

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

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

Study Officials

• Alastair O'Brien

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

APEACH Trial Team

CONTACT

0207 670 4813; cctu.apeach@ucl.ac.uk

Lee Webber

CONTACT

l.webber@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Apixaban 2.5mg twice daily to prevent liver decompensation in patients with liver cirrhosis

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 24, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): March 30, 2031
• Last Updated: July 24, 2026

Record last verified: 2026-07