Oral Anti-coagulants in Fragile Patients With Percutaneous Endoscopic Gastrostomy and Atrial Fibrillation (ORIGAMI) Pilot Study

Study Overview
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Brief Summary
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Compelling evidences support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation. The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants stated that data have shown that administration in a crushed form (e.g. via a nasogastric tube), does not alter the bioavailability for apixaban, rivaroxaban, and edoxaban. However, at the moment, there are no evidences supporting unequivocally the use of DOAC via PEG. The purpose of this study is to evaluate the safety and efficacy of Edoxaban administered through PEG in patients with an indication of anticoagulation according to the current clinical practice.

Detailed Description
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Several studies support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation. The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants affirmed that data have shown that administration in a crushed form (e.g. via a nasogastric tube), does not alter the bioavailability for apixaban, rivaroxaban, and edoxaban. However, at the moment, there are no evidences supporting unequivocally the use of DOAC via Percutaneous endoscopic gastrostomy (PEG). PEG is a method developed throughout the early 1980s for patients who need long-term enteral nutrition due to neurodegenerative, neuromuscular and oncological diseases. This class of patients is expected to increase significantly in the next decade. Several studies have proven the safety of DOAC compared to VKA even recommending to prefer DOAC over VKA wherever possible in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. However, there is no evidence to support unequivocally the use of DOAC in patients fed PEG. The purpose of this study is to evaluate the safety and efficacy of Edoxaban administered through PEG in patients with an indication of anticoagulation according to the current clinical practice.

Official Title
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anticOagulanti oRali in pazIenti fraGili Con gAstrostoMia endoscopIca Percutanea e fIbrillazione Atriale

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Edoxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PEG and indication for treatment with long-term oral anticoagulant therapy Patients with Atrial Fibrillation Exclusion Criteria: Children under 18 years old. Life expectancy <30 days. Lack of informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with PEG and oral anticoagulan treatment<br>Patients with PEG and indication for treatment with long-term oral anticoagulant therapy due to non valvular atrial fibrillation (FNAV), according to the current guidelines. | Drug: Edoxaban<br>* Edoxaban will be administered via PEG in patients who are eligible for the anticoagulant treatment according to the current guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-embolic events | Description of the number of stroke, TIA and systemic embolism events symptomatic relapse of deep vein thrombosis/ pulmonary embolism in patients treated with Edoxaban via PEG. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding events | any bleeding described according to the Bleeding Academic Research Consortium (BARC) scale. Type 0= No bleeding Type 1 = Bleeding that is not actionable and does not cause the patient to seek treatment. Type 2 = hemorrhage that is actionable and requires diagnostic studies, hospitalization, or treatment by a health care professional. Type 3a = bleeding plus hemoglobin drop of 3 to < 5 g/dl; transfusion with overt bleeding. Type 3b = bleeding plus hemoglobin drop < 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents. Type 3c = Confirmed Intracranial hemorrhage or intraocular bleed compromising vision Type 4 = CABG-related bleeding within 48 hours Type 5a = Probable fatal bleeding Type 5b = Definite fatal bleeding Type 0-2 will be conisdered minor bleedings. Type 3-5 will be considered major bleedings | 1 month | 
| Anti-factor Xa assay | Description of the efficacy of the edoxaban by measuring th the anti-FXa activity. | within 1 month |