Oral Anti-coagulants in Fragile Patients With Percutaneous Endoscopic Gastrostomy and Atrial Fibrillation (ORIGAMI) Pilot Study
NCT ID: NCT04271293
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2020-04-07
2021-08-10
Brief Summary
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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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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Edoxaban
Edoxaban will be administered via PEG in patients who are eligible for the anticoagulant treatment according to the current guidelines.
Interventions
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Edoxaban
Edoxaban will be administered via PEG in patients who are eligible for the anticoagulant treatment according to the current guidelines.
Eligibility Criteria
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Inclusion Criteria
* Patients with Atrial Fibrillation
Exclusion Criteria
* Life expectancy \<30 days.
* Lack of informed consent.
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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DAMARIO DOMENICO
Principal Investigator
Principal Investigators
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Domenico D'Amario
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Gemelli IRCCS
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Countries
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References
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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.
Cappannoli L, Laborante R, Galli M, Canonico F, Ciliberti G, Restivo A, Princi G, Arcudi A, Sabatelli M, De Cristofaro R, Crea F, D'Amario D. Feasibility, effectiveness, and safety of edoxaban administration through percutaneous endoscopic gastrostomy: 12-months follow up of the ORIGAMI study. Front Cardiovasc Med. 2022 Dec 22;9:1052053. doi: 10.3389/fcvm.2022.1052053. eCollection 2022.
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.
Other Identifiers
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2897
Identifier Type: -
Identifier Source: org_study_id