A Real-World, Prospective, Observational Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto®) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent AEs
研究概览
简要总结
This study is planned to collect prospective data and evaluate the safety and effectiveness of rivaroxaban for the prevention of stroke and systemic embolism in Indian patients with NVAF when used in clinical practice under real-life conditions.
The study will be conducted in routine clinical practice settings. Approximately 1000 patients from India will be enrolled in this study. Patients will be observed for maximum period of 12 months after the start of Xarelto treatment or until it is no longer possible (e.g. lost to follow-up, death, withdrawal) before the end of the observation period.
The decision by the investigator to start with of Xarelto must be independent of the inclusion of a patient to the study.
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
- •Patient should be an adult female or male, ≥18 years of age;
- •Patient should be diagnosed with NVAF and initiated with rivaroxaban treatment for prevention of stroke or systemic embolism per investigator's routine treatment practice;
- •Patient should not have received rivaroxaban in the past;
- •Patient/patient's legally acceptable representative should be willing to provide written informed consent.
排除标准
- •Patient has contraindications to receive rivaroxaban therapy according to local prescribing information;
- •Patient is receiving anticoagulant therapy for indication other than NVAF and that needs to be continued as per discretion of treating physician;
- •Patient is participating in an investigational program with interventions outside of routine clinical practice.
研究组 & 干预措施
Treatment
Rivaroxaban treatment-naïve patients, at least 18 years of age and presenting with NVAF will be considered eligible for participation in this study only after the decision to treat with rivaroxaban has been made by the treating physician.
干预措施: Rivaroxaban (Xarelto,Bay 59-7939) (Drug)
结局指标
主要结局
Incidence of treatment-emergent AEs
时间窗: Up to 18 months
Incidence of major bleeding events
时间窗: Up to 18 months
Major bleeding events include: * Fatal bleeding * Symptomatic bleeding in a critical area or organ * Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. * Hemoglobin level; or * Need for transfusion of packed red blood cells or whole blood.
Incidence of all-cause death
时间窗: Up to 18 months
Deaths will be adjudicated as either vascular (e.g., due to stroke, embolism, myocardial infarction, or arrhythmia) or non-vascular (e.g., malignancy or infection).
Incidence of treatment-emergent SAEs
时间窗: Up to 18 months
次要结局
- Non-major bleeding events(Up to 18 months)
- AE rates in the different NVAF risk factor categories(Up to 18 months)
- Incidence of symptomatic thromboembolic events(Up to 18 months)
- Treatment persistence with rivaroxaban(Up to 18 months)
- SAE rates in the different NVAF risk factor categories(Up to 18 months)