NCT02973984招募中不适用
Evaluating the Efficacy and Risks of Anticoagulant Treatments in Multimorbid Frail Older Subjects With Atrial Fibrillation. The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)
Alberto Pilotto1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2016年11月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- all-cause mortality and vascular mortality
研究概览
简要总结
Preliminary data suggest that:
- a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF);
- the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF;
- considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.
详细描述
The main objective of this observational study is to evaluate in a "real world" population of older hospitalized patients with AF, the clinical benefit/risk ratio of the anticoagulant treatments in terms of:
- mortality (all-cause and vascular mortality);
- thromboembolic events, i.e. stroke, systemic embolism;
- bleeding side-effects, especially intracranial and gastrointestinal bleeding Secondary objective of the study is to evaluate whether a different prognostic profile, as determined by the MPI, is associated with 1) different kind of treatments for AF (no treatment vs anticoagulants, i.e. Vitamin K Antagonists (VKA) or novel oral anticoagulant (NOACs); and 2) differences in the main outcomes (i.e. mortality, major thromboembolic events and side effects including bleeding events).
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This is an observational study in which all consecutive patients admitted to the Geriatrics Units involved in the project will be screened for inclusion. The inclusion criteria are:
- •patients of both genders, aged 65 years and older
- •admitted to hospital for acute diseases or a relapse of chronic diseases
- •with a documented diagnosis of non valvular AF
- •who are willing to participate in the survey and give their informed consent
排除标准
- •age less than 65 years
- •patients who have not provided informed consent
结局指标
主要结局
all-cause mortality and vascular mortality
时间窗: 12 months
Vascular mortality is defined as: stroke, embolism, myocardial infarction
bleeding side-effects
时间窗: 12 months
major intracranial and gastrointestinal bleeding.
thromboembolic events,
时间窗: 12 months
stroke and/or systemic embolism
次要结局
- MPI value and different mortality risk class(12 months)
- vascular-related hospitalization rates(12 months)
- bleeding-related hospitalization rates(12 months)
- presence/absence of anticoagulant treatments(12 months)
研究者
Alberto Pilotto
Director of Department Geriatric Care, OrthoGeriatrics and Rehabilitation
Ente Ospedaliero Ospedali Galliera
研究点 (1)
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