Edoxaban Performance in Senior Citizen With Non-valvular Atrial Fibrillation Evaluated Per Frailty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
Edoxaban, has shown in clinical registration trials a significant reduction of major bleeding compared to warfarin, especially in elderly patients. Efficacy and safety of edoxaban will be assessed in a cohort of very elderly patients (≥80 years of age) with NVAF. A secondary analysis will correlate outcomes with frailty defined according to SHARE-FI (not-frail, pre-frail or frail).
详细描述
Aim of the study To assess the efficacy and safety of edoxaban in a cohort of very elderly patients (≥80 years of age) with NVAF.
Edoxaban has never been tested in elderly frail patients. In both sexes, there is a non-linear association between age and frailty. A secondary analysis according to frailty assessment (not-frail, pre-frail or frail) will be also performed.
Study Design Observational prospective cohort study including patients of ≥80 years of age with a new diagnosis of NVAF. Edoxaban 60 mg (or 30 mg for patients with CrCL 15 - 50 mL/min or with body weight ≤ 60 kg) will be administered to all patients. All participants will be stratified according to frailty, as assessed by SHARE-FI score, to non-frail, pre-frail, and frail.
Study Population Patients of both sexes, of ≥80 years of age with a new diagnosis of non-valvular atrial fibrillation and without contraindications to Edoxaban.
Outcomes
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NVAF diagnosed in the past 30 days
- •Age at baseline of 80 years or older with indication for anticoagulation treatment with edoxaban
排除标准
- •NVAF diagnosed more than 30 days prior to baseline visit
- •Other OAT, except for warfarin or LMWH, already started at the time of baseline visit
- •Patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis
- •Severe hepatic impairment (defined as Child-Pugh Class B or C or increase in transaminases more than three times the upper reference value of normality) or hepatic disease associated with coagulopathy
- •Elevated liver enzymes (ALT/AST > 2 x ULN) or total bilirubin ≥ 1.5 x ULN at baseline
- •Recent (within 1 month) or persisting gastrointestinal ulceration
- •Active neoplasm
- •Known or suspected oesophageal varices
- •Arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
- •Life expectancy <1 year
- •Concomitant use of strong P-gp drugs which contraindicate edoxaban use12 (e.g. HIV protease inhibitors)
- •Clinically significant active bleeding or high risk of bleeding conditions such as: recent brain or spinal injury; recent brain, spinal or ophthalmic surgery; recent intracranial haemorrhage
- •Known contraindications or hypersensitivity to the active substance or to any of the excipients of Lixiana
- •Lack of acquisition of informed consent or refusal to participate by the subject or family representative
结局指标
主要结局
Death
时间窗: Through study completion, an average of 24 months
Divided into cardiovascular death, fatal bleeding and other causes of death
Cumulative incidence of arterial ischemic events, major bleeding, and clinically relevant non-major bleeding
时间窗: Through study completion, an average of 24 months
Cumulative incidence of arterial ischemic events (stroke/TIA and systemic embolism), major bleeding according to ISTH definition, and clinically relevant non-major bleeding (bleeding not meeting major bleeding criteria but considered clinically significant).
次要结局
- Death(Through study completion, an average of 24 months)
- Correlation of frailty, as measured with Survey of Health, Ageing and Retirement in Europe - Frailty Instrument, with the cumulative incidence of stroke/TIA, systemic embolism, major bleeding and clinically relevant non-major bleeding.(24 months)
研究者
Vittorio Pengo
Associate Professor
University of Padova