Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 493
- 试验地点
- 1
- 主要终点
- Major bleeding events
研究概览
简要总结
In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. Only patients suffering from decreased renal function and irregular heart beat will be considered. The study plans to include 500 Taiwanese adult male and female patients with the age above 20 years. Patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients ≥ 20 years of age
- •Diagnosis of non-valvular atrial fibrillation (NVAF)
- •Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
- •Previously documented CrCl of 15-50 mL/min within 6 months before enrollment (last available value)
排除标准
- •Contraindications for rivaroxaban according to the local market authorization/ Summary of Product Characteristics
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
- •Planned treatment with other anticoagulants
- •Expected renal-replacement therapy within the next 3 months
研究组 & 干预措施
Rivaroxaban
Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE).
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Major bleeding events
时间窗: Up to 12 months
次要结局
- Occurrence of adverse events (AEs) and serious adverse events (SAEs)(Up to 12 months)
- Occurrence of All-cause mortality(Up to 12 months)
- Occurrence of symptomatic thromboembolic events(Up to 12 months)
- Occurrence of non-major bleeding events(Up to 12 months)
- Day(s) of rivaroxaban treatment: start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy (in case of treatment discontinuation, switch, or interruption, the reason will be recorded)(Up to 12 months)
- Changes in creatinine clearance (CrCl) from baseline(Up to 12 months)