Maggiore della Carita University Hospital
Domenico D'Amario
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.
Atrial Fibrillation
Fragility
Edoxaban
No Edoxaban
NA
Direct oral anticoagulants (DOAC) have a remarkable efficacy/safety ratio, a predictable anticoagulant effect and are recommended by ESC guidelines to be preferred over vitamin K antagonist (VKA) wherever possible in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Enteral access feeding devices are placed in patients who have a functional and accessible gastrointestinal tract but are not able to maintain an adequate oral intake. Among these devices, percutaneous endoscopic gastrostomy (PEG) represents a valid option, especially for long-term feeding, and PEG positioning has shown a steadily increasing trend in fragile patients with several comorbidities. A significant subgroup of subjects with PEG tube has an indication to long-term anticoagulant therapy, mainly represented by atrial fibrillation. Among the several pharmacodynamic pathway mediating anticoagulation, direct FXa inhibitors block both free FXa and FXa bound to form the prothrombinase complex, whereas the indirect FXa inhibitors, such as LMHW, only inhibit free FXa. It was recently described a safe and effective anticoagulation through the administration of edoxaban 30 mg daily (crushed and diluted in 10 mL of saline solution) through a PEG in a patient with advanced amyotrophic lateral sclerosis, tracheostomy, atrial fibrillation, and a recent acute heart failure. On these premises, the investigators designed the ORal anti-coagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation (ORIGAMI) pilot investigation, evaluating the feasibility, anticoagulant effectiveness and preliminary safety and efficacy of edoxaban administration via PEG in fragile patients with NVAF requiring long-term anticoagulation treatment. The ORIGAMI II study will be a prospective, multi-centre, double arm, open label, clinical trial, aiming to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines. One arm will receive Edoxaban through PEG and the other arm will receive other DOACs through PEG or subcutaneous heparin or LMWH. The study will enroll 168 patients, who will be followed-up for 12 months. The Centers that will participate in this study will be: the AOU Maggiore della Carità of Novara (as coordinating center); Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma; Ospedale Policlinico San Martino, Genova. The primary endpoint of this study is the difference in Anti-Clot treatment scale questionnaire results among the two groups assessed at 12 months.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 168 participants |
| Masking : | SINGLE |
| Masking Description : | 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 |
| Primary Purpose : | TREATMENT |
| Official Title : | EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation: the ORIGAMI II Study |
| Actual Study Start Date : | 2024-02-01 |
| Estimated Primary Completion Date : | 2025-01-31 |
| Estimated Study Completion Date : | 2025-01-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
San Martino Polyclinic Hospital
Genova, Italy, 16132
RECRUITING
AOU Major of Charity
Novara, Italy, 28100
RECRUITING
Agostino Gemelli University Hospital Foundation IRCCS
Roma, Italy, 00168