Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: 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
- 3,055
- 主要终点
- Number of Major bleeding events
研究概览
简要总结
This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.
详细描述
3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.
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
- 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 diagnosed with non-valvular atrial fibrillation
- •Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator's routine treatment practice
排除标准
- 未提供
研究组 & 干预措施
Rivaroxaban (Xarelto, BAY 59-7939)
Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban to prevent stroke or non-CNS systemic embolism has been made.
干预措施: Rivaroxaban (Xarelto, BAY 59-7939) (Drug)
结局指标
主要结局
Number of Major bleeding events
时间窗: Up to 30 months
Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with: 1. a fall in haemoglobin of ≥2 g/dL, or 2. a transfusion of ≥2 units of packed red blood cells or whole blood, or 3. occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or 4. death
次要结局
- Number of Symptomatic thromboembolic events(Up to 30 months)
- Treatment satisfaction questionnaire(Up to 30 months)
- Number of Non-major bleeding(Up to 30 months)
- Number of each reason for any switch from or interruption of rivaroxaban treatment(Up to 30 months)
- Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories(Up to 30 months)