Using Edoxaban for Fragile Patients with Atrial Fibrillation and PEG Feeding
EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation: the ORIGAMI II Study
This study is testing if the blood thinner Edoxaban works well for patients with atrial fibrillation who are fed through a tube, compared to other blood thinners, to see how it affects their health over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 3 sites (Genova and 2 other locations) |
| Trial ID | NCT06285942 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the use of Edoxaban, an oral anticoagulant, administered through a percutaneous endoscopic gastrostomy (PEG) in patients requiring long-term anticoagulation therapy due to atrial fibrillation. Participants will be divided into two groups: one receiving Edoxaban and the other receiving alternative anticoagulants. The study will assess the effectiveness of Edoxaban by measuring anti-FXa activity and thrombin generation, along with patient-reported outcomes using the Anti-Clot treatment scale questionnaire at 12 months. The goal is to determine the differences in treatment outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates include patients with a PEG tube who have an indication for long-term oral anticoagulation due to atrial fibrillation.
Not a fit: Patients under 18 years of age, those with a life expectancy of less than 30 days, or those with contraindications to direct oral anticoagulants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anticoagulation option for fragile patients with atrial fibrillation who are unable to take oral medications.
How similar studies have performed: While the use of Edoxaban in this specific population is novel, previous studies have shown success with direct oral anticoagulants in similar patient groups.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PEG (recent implantation or already present) * Indication for long-term oral anticoagulation Exclusion Criteria: * Under 18 years of age * Life expectancy \<30 days * Lack of informed consent * Contraindication to DOACs
Where this trial is running
Genova and 2 other locations
- Ospedale Policlinico San Martino — Genova, Italy (Recruiting)
- AOU Maggiore della Carità — Novara, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.