EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation
NCT ID: NCT06285942
Last Updated: 2024-02-29
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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RECRUITING
NA
168 participants
INTERVENTIONAL
2024-02-01
2025-01-31
Brief Summary
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Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.
The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months.
Detailed Description
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A significant subgroup of subjects with PEG tube has an indication to long-term anticoagulant therapy, mainly represented by atrial fibrillation. Among the several pharmacodynamic pathway mediating anticoagulation, direct FXa inhibitors block both free FXa and FXa bound to form the prothrombinase complex, whereas the indirect FXa inhibitors, such as LMHW, only inhibit free FXa. It was recently described a safe and effective anticoagulation through the administration of edoxaban 30 mg daily (crushed and diluted in 10 mL of saline solution) through a PEG in a patient with advanced amyotrophic lateral sclerosis, tracheostomy, atrial fibrillation, and a recent acute heart failure. On these premises, the investigators designed the ORal anti-coagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation (ORIGAMI) pilot investigation, evaluating the feasibility, anticoagulant effectiveness and preliminary safety and efficacy of edoxaban administration via PEG in fragile patients with NVAF requiring long-term anticoagulation treatment.
The ORIGAMI II study will be a prospective, multi-centre, double arm, open label, clinical trial, aiming to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines. One arm will receive Edoxaban through PEG and the other arm will receive other DOACs through PEG or subcutaneous heparin or LMWH.
The study will enroll 168 patients, who will be followed-up for 12 months. The Centers that will participate in this study will be: the AOU Maggiore della Carità of Novara (as coordinating center); Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma; Ospedale Policlinico San Martino, Genova.
The primary endpoint of this study is the difference in Anti-Clot treatment scale questionnaire results among the two groups assessed at 12 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Edoxaban
This arm will receive Edoxaban via PEG
Edoxaban
To use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines
No Edoxaban
This arm will receive other DOACs through PEG or subcutaneous heparin or LMWH
No Edoxaban
Other DOACs through PEG or subcutaneous heparin or LMWH
Interventions
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Edoxaban
To use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines
No Edoxaban
Other DOACs through PEG or subcutaneous heparin or LMWH
Eligibility Criteria
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Inclusion Criteria
* Indication for long-term oral anticoagulation
Exclusion Criteria
* Life expectancy \<30 days
* Lack of informed consent
* Contraindication to DOACs
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
Responsible Party
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Domenico D'Amario
Professor
Locations
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Ospedale Policlinico San Martino
Genova, , Italy
AOU Maggiore della CaritÃ
Novara, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Countries
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Facility Contacts
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Pietro Ameri, Prof
Role: primary
Domenico D'Amario, Prof
Role: primary
Cristiano Spada, Prof
Role: primary
References
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Galli M, Andreotti F, Porto I, Crea F. Intracranial haemorrhages vs. stent thromboses with direct oral anticoagulant plus single antiplatelet agent or triple antithrombotic therapy: a meta-analysis of randomized trials in atrial fibrillation and percutaneous coronary intervention/acute coronary syndrome patients. Europace. 2020 Apr 1;22(4):538-546. doi: 10.1093/europace/euz345.
Galli M, Porto I, Andreotti F, D'Amario D, Vergallo R, Della Bona R, Crea F. Early anticoagulation in the current management of NSTE-ACS: Evidence, guidelines, practice and perspectives. Int J Cardiol. 2019 Jan 15;275:39-45. doi: 10.1016/j.ijcard.2018.10.087. Epub 2018 Oct 27.
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.
D'Amario D, Galli M, Cappannoli L, Canonico F, Restivo A, Arcudi A, Scacciavillani R, Riccioni ME, Vergallo R, Montone RA, Conte A, Meleo E, Lancellotti S, Sacco M, Antonelli M, Andreotti F, DE Cristofaro R, Crea F. Oral anticoagulants in fragile patients with percutaneous endoscopic gastrostomy and atrial fibrillation: the ORIGAMI pilot investigation. Minerva Cardiol Angiol. 2023 Feb;71(1):109-116. doi: 10.23736/S2724-5683.21.05903-2. Epub 2022 Feb 15.
Other Identifiers
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CE366/2023
Identifier Type: REGISTRY
Identifier Source: secondary_id
277.535
Identifier Type: -
Identifier Source: org_study_id