[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506069":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cirrhotic patients with Child A or B under apixaban","EXPERIMENTAL","Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of apixaban (Eliquis®) for 7 consecutive days.\n\nBlood samples will be collected just before and after apixban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9.\n\nIn vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters \\[ST Genesia (Drugscreen)\\], as well as peak and trough apixaban levels will be measured.",[13],"Drug: Apixaban 5 MG [Eliquis]",{"label":15,"type":10,"description":16,"interventionNames":17},"Cirrrhotic patients with Child A or B under edoxaban","Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of edoxaban (Lixiana®) for 7 consecutive days.\n\nBlood samples will be collected just before and after edoxaban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9.\n\nIn vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters \\[ST Genesia (Drugscreen)\\], as well as peak and trough edoxaban levels will be measured.",[18],"Drug: Edoxaban 60 MG [Lixiana]",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Apixaban 5 MG [Eliquis]","Pharmacokinetics and pharmacodynamics assessment of apixaban in patients with Child A or B liver cirrhosis",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Edoxaban 60 MG [Lixiana]","Pharmacokinetics and pharmacodynamics assessment of edoxaban in patients with Child A or B liver cirrhosis",[15],[31],{"name":32,"affiliation":33,"role":34},"Lorenzo Alberio, Prof Dr. med","CHUV","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","0041213140171","lorenzo.alberio@chuv.ch",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Centre Hospitalier Universitaire Vaudois (CHUV)","RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],6.63282,46.516,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":25,"email":39},"Lorenzo Alberio, Prof. Dr.","+41 21 314 01 71",{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lorenzo ALBERIO","Prof Dr. méd","100506069","phase-2-doac-in-patients-with-child-a-or-b-liver-cirrhosis-100506069",false,"NCT05869591","DOAC in Patients with Child a or B Liver Cirrhosis","Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis","CIRROAC","Inclusion Criteria:\n\n* Age 18 years or older\n* Patient with previously diagnosed liver cirrhosis Child A or B\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Oesophageal varices with grade superior to 1 or with red signs\n* Active ulcer disease of the gastrointestinal tract\n* History of haemorrhagic stroke\n* Severe uncontrolled hypertension\n* Recent brain, spinal or ophthalmic surgery\n* Kidney function inadequate for DOAC treatment\n* Concomitant treatment with anti-platelet drugs\n* Concomitant treatment with anticoagulant drugs (VKA, LMWH, DOAC)\n* Any contraindications for DOAC administration\n* Inability to give informed consent","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The goal of this clinical trial is to investigate pharmacokinetics and pharmacodynamics of direct oral anticoagulant drugs (DOAC), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis (LC). The primary objective of this study is to verify the ability of apixaban and edoxaban to decrease in vivo thrombin generation in LC patients.\n\nParticipants will be randomly assigned to either apixaban (Eliquis®) or edoxaban (Lixiana®) at a therapeutic dosage for 7 consecutive days.\n\nThe results of this investigation will contribute to designing a prospective multicentre interventional study to investigate the efficacy of DOAC to improve clinical outcomes in patients with LC",[80],"Liver Cirrhosis",[82,83,84,85],"Cirrhosis","DOAC","Thrombin generation","Anticoagulation","2025-02-11",{"date":88,"type":89},"2025-02-13","ACTUAL",{"date":91,"type":89},"2024-01-18",{"date":93,"type":74},"2026-06",{"name":5,"class":6},1]