[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429619":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":41,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":41,"enrollmentInfo":73,"targetDuration":41,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":46,"whyStopped":41,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rivaroxaban","EXPERIMENTAL","Pharmacokinetics and pharmacodynamics of rivaroxaban",[13],"Drug: Rivaroxaban 10 mg Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Apixaban","Pharmacokinetics and pharmacodynamics of apixaban",[18],"Drug: Apixaban 2.5 mg Oral Tablet",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Rivaroxaban 10 mg Oral Tablet","Administration of one single dose of rivaroxaban (10 mg) in tablet form.",[9],[26],"Xarelto",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Apixaban 2.5 mg Oral Tablet","Administration of one single dose of apixaban (2.5 mg) in tablet form.",[15],[32],"Eliquis",[34],{"name":35,"affiliation":5,"role":36},"Dr. med. Guido Stirnimann","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+41 31 632 47 13",null,"guido.stirnimann@insel.ch",[44],{"facility":45,"status":46,"city":47,"state":41,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne","RECRUITING","Bern","3010","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],7.44744,46.94809,{"lat":55,"lon":54},[58],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":60,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[62],{"name":63,"class":6},"Centre Hospitalier Universitaire Vaudois","100429619","phase-1-direct-oral-anticoagulants-rivaroxaban-and-apixaban-in-patients-with-liver-cirrhosis-100429619",false,"NCT04874428","Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis","Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis","Inclusion Criteria:\n\n* Age 18 years or older\n* Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B).\n* Written informed consent\n\nExclusion Criteria:\n\n* Positive pregnancy test (only for women in childbearing age with intact uterus), pregnancy or nursing women\n* Intake of prophylactic or therapeutic oral anticoagulant (phenprocoumon, acenocoumarol, dabigatran etc.) 2 weeks prior to inclusion in the study\n* Application of parenteral anticoagulant, e.g. unfractionated heparin, low molecular weight heparins, heparin derivatives (fondaparinux etc.) 1 week prior to inclusion in the study\n* Pharmacologic platelet inhibition within 2 weeks prior to inclusion in the study\n* Known coagulation disorders (e.g. von Willebrand's disease, hemophilia)\n* Active, clinically significant bleeding\n* Congenital or acquired bleeding disorder\n* High risk of bleeding (e.g. active ulcerative gastrointestinal disease)\n* Uncontrolled severe hypertension\n* Vascular retinopathy\n* Acute infection\n* Acute bacterial endocarditis\n* Severe anemia (haemoglobin ≤100 g\u002FL)\n* Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption\n* Severe liver dysfunction (Child-Pugh Score grade C)\n* Hepatic encephalopathy ≥ grade 3\n* Severe renal impairment with a creatinine clearance (GFR) of \\\u003C30 ml\u002Fmin\n* Known intolerance to the study medications rivaroxaban and\u002For apixaban\n* Concomitant treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, lopinavir, ritonavir, indinavir).\n* Concomitant treatment with a P-glycoprotein inhibitor and a weak or moderate CYP3A4 inhibitor (e.g., erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine).\n* Concomitant treatment with a P-glycoprotein inducer and a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampicin).\n* Wash-out period of less than two weeks prior to the application of study drug in case of prior treatment with a strong CYP3A4 inhibitor or a P-glycoprotein inhibitor and weak or moderate CYP3A4 inhibitor or with a P-glycoprotein inducer or strong CYP3A4 inducer.","ALL","18 Years",{"count":74,"type":75},24,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B).\n\nThe enrolled participants receive a prophylactic single oral dose of either rivaroxaban (10 mg) or apixaban (2.5 mg) at around 8 a.m. on the day of the trial. Blood samples are taken 0.5 hours pre-dose and 1, 2, 3, 4, 6, 8, 12 hours post-dose.\n\nA follow-up telephone call is performed 5 days after the study intervention to collect safety data.",[81],"Liver Cirrhosis",[9,15,83,84,85,86,87,88,89,90,91,92,93,94,95,81,96],"Factor Xa Inhibitors","Antithrombins","Serine Proteinase Inhibitors","Protease Inhibitors","Enzyme Inhibitors","Anticoagulants","Pharmacokinetics","Pharmacodynamics","Thromboembolism","Venous Thromboembolism","Embolism and Thrombosis","Vascular Diseases","Cardiovascular Diseases","Liver Diseases","2026-08-18",{"date":99,"type":100},"2026-08-19","ACTUAL",{"date":102,"type":100},"2021-05-19",{"date":104,"type":75},"2026-12",{"name":5,"class":6},1]