[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519615":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":32,"collaborators":25,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":25,"enrollmentInfo":43,"targetDuration":25,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"University Hospital, Caen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Warfarin","ACTIVE_COMPARATOR","Warfarin (Coumadine): INR target \\[2.0-3.0\\]",[13],"Drug: Anticoagulation Agents",{"label":15,"type":16,"description":17,"interventionNames":18},"Apixaban","EXPERIMENTAL","Apixaban (Eliquis) at 2.5mg, per os, twice a day",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Anticoagulation Agents","anticoagulation in peritoneal dialysis patients with non valvular atrial fibrillation during one year",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Laure Peyro-saint-paul","CONTACT","233 31065342","peyrosaintpaul-l@chu-caen.fr",{"type":33,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100519615","phase-3-safety-and-efficacy-of-apixaban-versus-warfarin-in-peritoneal-dialysis-patients-with-non-valvular-atrial-fibrillation-a-prospective-randomised-open-label-blinded-end-point-trial-apidp2-100519615",false,"NCT06045858","Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation: a Prospective, Randomised, Open-label, Blinded End-point Trial (APIDP2)","APIDP2","Inclusion criteria\n\n* Males and females, age at least 18 years, in ESRD treated with peritoneal dialysis for ≥ 3 months\n* Patients with a history of non valvular AF treated by oral anticoagulation or patients initiating oral anticoagulation for a diagnosis of non valvular AF\n* CHA2DS2-VASc score of ≥ 2.\n* For women of childbearing age who are sexually active, use of an effective method of contraception for up to 10 days after the end of treatment and a negative blood pregnancy test at enrollment.\n* Signature of informed consent\n\nExclusion criteria\n\n* Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin \\\u003C8.5g\u002FdL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)\n* Moderate or severe mitral stenosis\n* Patients with a history of transient ischemic attack or stroke in the 3 months prior to inclusion\n* Patient treated with haemodyalisis\n* Conditions other than non valvular AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism\n* Life expectancy \\\u003C 3 months\n* Anticipated kidney transplant within the next 3 months\n* Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, postpartum women, breastfeeding mothers, individuals deprived of their liberty by judicial or administrative decision, minors, individuals under legal protection such as guardianship or trusteeship).\n* Women of childbearing age not using a highly effective contraceptive method during the study and up to 10 days after the end of treatment.\n* Use of potent inducers of CYP3A4 (particularly rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort (Hypericum perforatum)).\n* Use of CYP3A4 and P-gp inhibitors, particularly azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), HIV protease inhibitors, clarithromycin, and erythromycin.\n* Contraindication to anticoagulant treatment, such as antiphospholipid syndrome.","ALL","18 Years",{"count":44,"type":45},178,"ESTIMATED","INTERVENTIONAL",[48],"PHASE3","Introduction:\n\nSeveral randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibrillation (NVAF) to prevent thromboembolic events, in the general population. There is a growing interest in the use of apixaban in patients with End-Stage Renal-Disease (ESRD) undergoing peritoneal dialysis but there is a lack of randomised data in this population.\n\nDesign: APIDP2 is a prospective parallel randomised, open-label, blinded endpoint trial.\n\nParticipants: Patients with ESRD undergoing chronic Peritoneal Dialysis who have NVAF.\n\nSetting: A total of 178 participants will be recruited from 20 French peritoneal dialysis centers.\n\nIntervention: Eligible patients will be randomly assigned to receive either apixaban at a reduced dose 2.5mg twice daily (dose determined with the previous pharmacokinetic study APIDP1 of apixaban in PD patients) or dose-adjusted to INR target \\[2-3\\] coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of one year.\n\nThe primary outcome is a major or clinically relevant non-major bleeding from randomisation up to Month 12, assessed according to ISTH score. Secondary outcomes encompass an efficacy composite criterion combining stroke or TIA, cardiovascular death, and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to GUSTO and TIMI criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of \\[2-3\\] in the warfarin arm over one year, and AntiXa apixaban activity in case of bleeding events and at 1, 6, and 12 months of follow-up in the apixaban arm.\n\nPrimary outcome analysis: To demonstrate that apixaban is safer than warfarin at one year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found in the ARISTOTLE study among patients with CrCl \\[25-30\\]ml\u002Fmin), i.e. 89 patients per group.",[51,52],"Atrial Fibrillation","Peritoneal Dialysis Complication",[54,55,56,57],"peritoneal dialysis","atrial fibrillation","anticoagulation","randomized controlled trial","NOT_YET_RECRUITING","2024-08-08",{"date":61,"type":62},"2024-08-09","ACTUAL",{"date":64,"type":45},"2024-10-30",{"date":66,"type":45},"2027-10-30",{"name":5,"class":6}]