[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648769":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":17,"responsibleParty":44,"collaborators":46,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":17,"enrollmentInfo":85,"targetDuration":17,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":17,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":17},{"fullName":5,"class":6},"University College, London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants randomised to receive Apixaban 2.5mg oral tablet twice daily","PLACEBO_COMPARATOR","Participants randomised to receive a matching placebo",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Participants randomised to receive Apixaban 2.5mg twice daily","EXPERIMENTAL",null,[19],"Drug: Apixaban 2.5 mg twice daily",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":17},"DRUG","Apixaban 2.5 mg twice daily","Participants randomised to this arm will receive Apixaban 2.5mg twice daily",[15],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":17},"Placebo","Placebo will be given as oral tablet and taken twice daily",[9],[31],{"name":32,"affiliation":33,"role":34},"Alastair O'Brien","Queen Mary University of London","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":17,"email":40},"APEACH Trial Team","CONTACT","0207 670 4813","cctu.apeach@ucl.ac.uk",{"name":42,"role":38,"phone":17,"phoneExt":17,"email":43},"Lee Webber","l.webber@ucl.ac.uk",{"type":45,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[47,49,51,53,55,58,60,62,64,66,68,70,73],{"name":48,"class":6},"Royal Free Hospital NHS Foundation Trust",{"name":50,"class":6},"NHS Greater Glasgow and Clyde",{"name":52,"class":6},"University Hospital of Wales",{"name":54,"class":6},"University of Nottingham",{"name":56,"class":57},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV",{"name":59,"class":6},"University Hospital Southampton NHS Foundation Trust",{"name":61,"class":6},"King's College Hospital NHS Trust",{"name":63,"class":6},"King's College London",{"name":65,"class":57},"Hull University Teaching Hospitals NHS Trust",{"name":67,"class":6},"Imperial College London",{"name":69,"class":6},"The Leeds Teaching Hospitals NHS Trust",{"name":71,"class":72},"The Royal London Hospital, UK","UNKNOWN",{"name":74,"class":72},"BRITISH LIVER TRUST","100648769","phase-3-apixaban-to-prevent-decompensation-of-early-liver-cirrhosis-trial-100648769",false,"NCT07726693","Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial","Apixaban to Prevent dEcompensation of eArly Liver CirrHosis Trial","APEACH","Inclusion Criteria:\n\n1. 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)\n2. 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\n3. Childs A Cirrhosis (Participants with a previous episode of decompensated cirrhosis who have now recompensated can be included)\n4. Participants with no hepatic encephalopathy or low-grade hepatic encephalopathy (Grade 0 or 1) taking lactulose and\u002For rifaximin\n5. Aged ≥18 years\n6. Clinical evidence of portal hypertension, defined as any 1 of:\n\n   * Evidence of abdominal collateral circulation, recanalised umbilical vein or varices on imaging\n   * Asymptomatic ascites (trace only) seen around the liver on imaging in patients who are not taking diuretics\n   * Liver stiffness measurement \\>20kPa on FibroScan®\u002F Vibration- Controlled Transient Elastography (VCTE) (where BMI \\\u003C35)\n   * Presence of Gastro-oesophageal varices at endoscopy\n   * Hepatic venous pressure gradient ≥ 10mmHg\n\nOr Platelet count \\\u003C 150,000 μL AND any 1 of:\n\n* Spleen size \\>13 cm in length\n* Liver stiffness measurement \\>20kPa on FibroScan®\u002FVCTE (where BMI \\>35)\n* Presence of portal hypertensive gastropathy at endoscopy\n\nExclusion Criteria:\n\n1. 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)\n2. Causes for cirrhosis other than alcohol, including those with MASLD who have never drunk alcohol above government recommended levels (14 units\u002Fweek)\n3. Pre-existing splanchnic vein thrombosis (portal, splenic, mesenteric, and hepatic veins)\n4. Use of (and need for) anticoagulation or dual antiplatelet therapy or clopidogrel\n5. Platelets \\\u003C50x109\u002FL at screening\n6. Moderate-severe renal impairment defined as eGFR \\\u003C30ml\u002Fmin at screening\n7. Recent variceal bleed or untreated large varices\n8. Malignancy in last 2 years if unlikely to survive trial because of comorbidity in the location PI's opinion\n9. Hepatocellular carcinoma\n10. Severe cardiac failure1 or Chronic Obstructive Pulmonary Disease (COPD)\n11. Pregnancy\n12. INR \\>1.7 (After vitamin K correction) at screening\n13. Previous hypersensitivity reaction to Apixaban","ALL","18 Years",{"count":86,"type":87},1142,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","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.\n\nIn 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.\n\nThe 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.\n\nPrevious 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.\n\nThe APEACH trial will include enough participants to make it clear whether Apixaban is helpful or not.",[93],"Liver Cirrhosis",[93,95,96,97,98],"Alcohol Related Liver Disease (ARLD)","Metabolic dysfunction-associated steatotic liver disease","Apixaban","MetALD","NOT_YET_RECRUITING","2026-07-21",{"date":102,"type":103},"2026-07-24","ACTUAL",{"date":105,"type":87},"2026-07-15",{"date":107,"type":87},"2031-03-30",{"name":5,"class":6}]