XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,101
- 主要终点
- Adjudicated major bleeding events
研究概览
简要总结
This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.
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
- •Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study.
排除标准
- 未提供
研究组 & 干预措施
Group 1
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Adjudicated major bleeding events
时间窗: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Safety variables will be summarized using descriptivestatistics based on adverse events collection
时间窗: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
All cause mortality
时间窗: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
次要结局
- Healthcare resource(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Adjudicated symptomatic thromboembolic events(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Treatment satisfaction(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Adverse events rates in the different AF risk factor categories(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Persistence with rivaroxaban treatment(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Reasons for switch of rivaroxaban treatment(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Reasons for interruption of rivaroxaban treatment(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)