Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285942
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-15
Brief Title:
EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation the ORIGAMI II Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORIGAMI II
Brief Summary:
The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH
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
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:
Direct oral anticoagulants DOAC have a remarkable efficacysafety ratio a predictable anticoagulant effect and are recommended by ESC guidelines to be preferred over vitamin K antagonist VKA wherever possible in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation Enteral access feeding devices are placed in patients who have a functional and accessible gastrointestinal tract but are not able to maintain an adequate oral intake Among these devices percutaneous endoscopic gastrostomy PEG represents a valid option especially for long-term feeding and PEG positioning has shown a steadily increasing trend in fragile patients with several comorbidities
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CE3662023 | REGISTRY | CET AOU Maggiore della Carità di Novara | None |