EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation
Status:
RECRUITING
Trial end date:
2025-01-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
NA
Details
Lead Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita