Xarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,216
- 试验地点
- 1
- 主要终点
- Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
研究概览
简要总结
The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.
详细描述
The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan)
- •Diagnosis of NVAF
- •Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
- •Treatment naïve regarding stroke prevention for atrial fibrillation
- •Signed informed consent
排除标准
- •Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC)
- •Patients participating in an investigational program with interventions outside of routine clinical practice
研究组 & 干预措施
Treatment-naïve NVAF patients in Korea and Taiwan
Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
时间窗: Up to one year
Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with: * A fall in hemoglobin of ≥2 g/dL, or * A transfusion of ≥2 units of packed red blood cells or whole blood, or * Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or * Death.
次要结局
- All-cause mortality(Up to one year)
- AEs(Up to one year)
- Non-major bleeding events(Up to one year)
- SAEs(Up to one year)
- Symptomatic thromboembolic events(Up to one year)
- Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy(Up to one year)