Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial | NCT07726693

NCT07726693

Overview

NCT ID: NCT07726693
Lead Sponsor: University College, LondonOTHER
Official Title: Apixaban to Prevent dEcompensation of eArly Liver CirrHosis Trial
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Jul 15, 2026Estimated
Primary Completion Date: Oct 31, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 1,142Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: APEACH Trial TeamContact
cctu.apeach@ucl.ac.uk0207 670 4813

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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