EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation: the ORIGAMI II Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• PEG (recent implantation or already present)

• Indication for long-term oral anticoagulation

Locations
Other Locations
Italy
Ospedale Policlinico San Martino
RECRUITING
Genova
AOU Maggiore della Carità
RECRUITING
Novara
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 168
Treatments
Experimental: Edoxaban
This arm will receive Edoxaban via PEG
Active_comparator: No Edoxaban
This arm will receive other DOACs through PEG or subcutaneous heparin or LMWH
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliero Universitaria Maggiore della Carita

This content was sourced from clinicaltrials.gov