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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Edoxaban

• Registration Number: NCT04271293
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-04-07
• Primary Completion: 2021-07-20
• Study Completion: 2021-08-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PEG and oral anticoagulan treatment	Edoxaban	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.

Primary Outcome Measures

Name	Time	Method
Cardio-embolic events	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Bleeding events	1 month	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
Anti-factor Xa assay	within 1 month	Description of the efficacy of the edoxaban by measuring th the anti-FXa activity.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy