NCT01750788已完成不适用
Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Asia: A Non-interventional Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,297
- 主要终点
- Adjudicated major bleeding events
研究概览
简要总结
This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.
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 (Central Nervous System) 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 descriptive statistics 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)
- 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)
- 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)
- Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
- Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study(after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later)
研究者
相似试验
已完成
不适用
Xarelto for Prevention of Stroke in Patients With Atrial FibrillationAtrial FibrillationNCT01606995Bayer6,784
已完成
不适用
Xarelto on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional StudyStrokeNCT02784717Bayer3,055
已完成
不适用
Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial FibrillationAtrial FibrillationNCT03284762Bayer1,216
已完成
不适用
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA RegionAtrial FibrillationNCT01800006Bayer2,101
已完成
不适用
Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial FibrillationNon-valvular Atrial Fibrillation (NVAF)NCT03746301Bayer924
