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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Edoxaban

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Atrial Fibrillation. Patients with PEG and indication for treatment with long-term oral anticoagulant therapy according to the guidelines.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with PEG and oral anticoagulan treatment; 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; Edoxaban will be administered via PEG in patients who are eligible for the anticoagulant treatment according to the current guidelines.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Domenico D'Amario, Fondazione Policlinico Gemelli IRCCS

Publications and helpful links

General Publications

• Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Collins R, Camm AJ, Heidbuchel H; ESC Scientific Document Group. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018 Apr 21;39(16):1330-1393. doi: 10.1093/eurheartj/ehy136.
• Salmonson T, Dogne JM, Janssen H, Garcia Burgos J, Blake P. Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA). Eur Heart J Cardiovasc Pharmacother. 2017 Jan;3(1):42-47. doi: 10.1093/ehjcvp/pvw032. Epub 2016 Dec 25.
• Tripodi A, Ageno W, Ciaccio M, Legnani C, Lippi G, Manotti C, Marcucci R, Moia M, Morelli B, Poli D, Steffan A, Testa S. Position Paper on laboratory testing for patients on direct oral anticoagulants. A Consensus Document from the SISET, FCSA, SIBioC and SIPMeL. Blood Transfus. 2018 Sep;16(5):462-470. doi: 10.2450/2017.0124-17. Epub 2017 Sep 13.
• Galli M, D'Amario D, Andreotti F, Porto I, Vergallo R, Sabatelli M, Lancellotti S, Meleo E, De Cristofaro R, Crea F. Sustained safe and effective anticoagulation using Edoxaban via percutaneous endoscopic gastrostomy. ESC Heart Fail. 2019 Aug;6(4):884-888. doi: 10.1002/ehf2.12434. Epub 2019 Jun 11.
• D'Amario D, Galli M, Canonico F, Restivo A, Arcudi A, Scacciavillani R, Cappannoli L, Riccioni ME, Annetta MG, Di Stefano G, Piccinni C, Vergallo R, Montone RA, Leone AM, Niccoli G, Sabatelli M, Antonelli M, Andreotti F, De Cristofaro R, Crea F. ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study. J Cardiovasc Med (Hagerstown). 2021 Mar 1;22(3):175-179. doi: 10.2459/JCM.0000000000001142.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: 2897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No