anticOagulanti oRali in pazIenti fraGili Con gAstrostoMia endoscopIca Percutanea e fIbrillazione Atriale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cardio-embolic events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PEG and indication for treatment with long-term oral anticoagulant therapy
- •Patients with Atrial Fibrillation
排除标准
- •Children under 18 years old.
- •Life expectancy <30 days.
- •Lack of informed consent.
研究组 & 干预措施
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.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Cardio-embolic events
时间窗: 1 month
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.
次要结局
- Bleeding events(1 month)
- Anti-factor Xa assay(within 1 month)
研究者
DAMARIO DOMENICO
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS