Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 977
- 试验地点
- 1
- 主要终点
- Assessment of the incidence of bleeding events
研究概览
简要总结
The main objective of this study is to realize an observational "real life" study conducted in French geriatric settings, to assess safety and efficacy in ≥ 80 year-old patients with nonvalvular Atrial fibrillation (AF) newly treated with Apixaban.
Moreover, in this geriatric population the adequacy of Apixaban dosage and events (bleeding and stroke) will be assessed.
详细描述
It is a muliticentric, observational, prospective study.
This study will be conducted in about 40 geriatric settings in France.
The planned duration of the inclusion period is 27 months in each center.
The follow-up period starts from inclusion up to one year after inclusion with phone contact or unscheduled visit at 3, 6, 9 and 12 months.
During this follow-up, participants physicians will record patients' data during visit directly from the patients or their physicians or their families and by phone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female patients aged 80 years and older.
- •Patients with non-valvular atrial fibrillation (documented on electrocardiography or other medical evidence like medical chart, hospital discharge note, physician's letter within 3 years before enrollment).
- •Followed in geriatric settings (office consultation, acute care, rehabilitation settings and nursing homes).
- •Newly treated (less than 6 months) with Apixaban (5mg twice daily (or 2.5 mg twice daily for patients with 2 of the following criteria : age > 80 years, creatinine > 133 μmol/l, weight < 60 kg)
排除标准
- •Patient refusing to participate.
- •Participation to a clinical trial.
- •Contraindication to use of Apixaban as described in the Summary of Product Characteristics .
结局指标
主要结局
Assessment of the incidence of bleeding events
时间窗: 12 months
次要结局
- Assessment of the risk of bleeding according the (HAS-BLED) Score(12 months)
- Assessment of compliance with treatment by (Apixaban) according (Morisky) Score(12 months)
- To determine bleeding risk according (ATRIA bleeding) score(12 months)
- To quantifie risk of hemorrhage according (HEMORR₂HAGES) Score(12 months)