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NCT07726693

PHASE3

Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial

Sponsor: University College, London

View on ClinicalTrials.gov

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.

Official title: Apixaban to Prevent dEcompensation of eArly Liver CirrHosis Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1142

Start Date

2026-07-15

Completion Date

2031-03-30

Last Updated

2026-07-24

Healthy Volunteers

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

Inclusion Criteria: 1. 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) 2. 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 3. Childs A Cirrhosis (Participants with a previous episode of decompensated cirrhosis who have now recompensated can be included) 4. Participants with no hepatic encephalopathy or low-grade hepatic encephalopathy (Grade 0 or 1) taking lactulose and/or rifaximin 5. Aged ≥18 years 6. 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 Exclusion Criteria: 1. 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) 2. Causes for cirrhosis other than alcohol, including those with MASLD who have never drunk alcohol above government recommended levels (14 units/week) 3. Pre-existing splanchnic vein thrombosis (portal, splenic, mesenteric, and hepatic veins) 4. Use of (and need for) anticoagulation or dual antiplatelet therapy or clopidogrel 5. Platelets \<50x109/L at screening 6. Moderate-severe renal impairment defined as eGFR \<30ml/min at screening 7. Recent variceal bleed or untreated large varices 8. Malignancy in last 2 years if unlikely to survive trial because of comorbidity in the location PI's opinion 9. Hepatocellular carcinoma 10. Severe cardiac failure1 or Chronic Obstructive Pulmonary Disease (COPD) 11. Pregnancy 12. INR \>1.7 (After vitamin K correction) at screening 13. Previous hypersensitivity reaction to Apixaban

Clinical Research Directory

Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria