Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean 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
- 924
- 试验地点
- 1
- 主要终点
- Incidence proportion of major bleeding
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those 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 ≥ 19 years of age
- •Diagnosis of NVAF
- •Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
- •Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
- •Written informed consent of the patient
排除标准
- •Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
- •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
Treatment
Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.
干预措施: Rivaroxaban(Xarelto,BAY 59-7939) (Drug)
结局指标
主要结局
Incidence proportion of major bleeding
时间窗: Up to 12 months
Incidence proportion of major bleeding events collects as serious or non-serious AEs and defined as overt bleeding associated with: * a fall in haemoglobin 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
- Occurrence of AEs and SAEs(Up to 12 months)
- Occurrence of all-cause mortality(Up to 12 months)
- Occurrence of Non-major bleeding(Up to 12 months)
- Incidence proportion of Symptomatic thromboembolic events(Up to 12 months)
- Days of rivaroxaban treatment(Up to 12 months)
- The change in creatinine clearance from baseline(At month 3,6,9 and 12)