protocolSection identificationModule nctId: NCT06285942, orgStudyIdInfo id: 277.535, secondaryIdInfos id: CE366/2023, type: REGISTRY, domain: CET AOU Maggiore della Carità di Novara, briefTitle: EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation, acronym: ORIGAMI II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH.Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months., conditionsModule conditions: Atrial Fibrillation, conditions: Fragility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: An interim-analysis will be performed on the primary endpoint when at least 50% of patients will have been randomized and completed the 6 months follow-up. The interim-analysis will be performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring board, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Edoxaban, interventions name: No Edoxaban, outcomesModule primaryOutcomes measure: Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months., secondaryOutcomes measure: Number of cardio-embolic events at 6 and12 months, secondaryOutcomes measure: Number of bleeding events, secondaryOutcomes measure: Assessment of drugs efficacy by measuring the anti-factor Xa activity, secondaryOutcomes measure: Assessment of drugs efficacy by measuring the thrombin generation, secondaryOutcomes measure: Assess the quality of life, secondaryOutcomes measure: Cost-effectiveness analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Pietro Ameri, Prof, role: CONTACT, phone: +39 010 3538975, email: pietro.ameri@unige.it, geoPoint lat: 44.40478, lon: 8.94438, locations facility: AOU Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Domenico D'Amario, Prof, role: CONTACT, phone: 0039 0321 3733141, email: domenico.damario@uniupo.it, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Cristiano Spada, Prof, role: CONTACT, phone: 06 30151, email: cristiano.spada@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False