ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study.
Aged
Aged, 80 and over
Anticoagulants
/ administration & dosage
Atrial Fibrillation
/ complications
Factor Xa Inhibitors
/ therapeutic use
Female
Follow-Up Studies
Gastroscopy
/ adverse effects
Gastrostomy
/ adverse effects
Humans
Male
Prospective Studies
Thromboembolism
/ etiology
Time Factors
Treatment Outcome
Journal
Journal of cardiovascular medicine (Hagerstown, Md.)
ISSN: 1558-2035
Titre abrégé: J Cardiovasc Med (Hagerstown)
Pays: United States
ID NLM: 101259752
Informations de publication
Date de publication:
01 Mar 2021
01 Mar 2021
Historique:
pubmed:
14
11
2020
medline:
15
12
2021
entrez:
13
11
2020
Statut:
ppublish
Résumé
The ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation (ORIGAMI) study investigates the safety and efficacy of Edoxaban administered via PEG in patients with atrial fibrillation and a clinical indication for a long-term anticoagulation. In this prospective, single-centre observational study, 12 PEG-treated patients with indication to anticoagulation will receive edoxaban via PEG and will be followed up to 6 months. Plasma antifactor Xa activity and edoxaban concentrations will be assessed. Thromboembolic (ischaemic stroke, systemic embolism, venous thromboembolism) and bleeding events (Bleeding Academic Research Consortium and Thrombolysis in Myocardial Infarction) will be recorded at 1 and 6 months. A retrospective analysis of five atrial fibrillation cases undergoing PEG implantation at our Institution who received edoxaban via PEG showed plasma anti-FXa levels at a steady state of 146 ± 15 ng/ml, without major adverse event at a mean follow-up of 6 months. ORIGAMI prospectively investigates PEG-administration of edoxaban in PEG-treated patients requiring long-term anticoagulation. Our preliminary retrospective data support this route of DOAC administration. NCT04271293.
Identifiants
pubmed: 33186237
pii: 01244665-202103000-00004
doi: 10.2459/JCM.0000000000001142
doi:
Substances chimiques
Anticoagulants
0
Factor Xa Inhibitors
0
Banques de données
ClinicalTrials.gov
['NCT04271293']
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
175-179Informations de copyright
Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.
Références
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