Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- incidence of major bleeding, non-major clinically relevant bleeding, minor bleeding events
研究概览
简要总结
From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up.
详细描述
To explore the appropriate dose of rivaroxaban to prevent stroke in elderly Chinese patients with nonvalvular atrial fibrillation in order to improve the effectiveness and safety of anticoagulation therapy. From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up. The efficacy indexes include stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack and myocardial infarction, and the safety indexes include major bleeding, non-major clinically relevant bleeding, minor bleeding events.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥75 years
- •Chinese patient: male or female
- •Patients had to be diagnosed as nonvalvular atrial fibrillation (NVAF)
排除标准
- •Patients with anemia (hemoglobin<100g/L), known human immunodeficiency virus infection, female patients who were pregnant or lactating and patients for whom warfarin was contraindicated, were also excluded
- •Patients with calculated creatine clearance vulue<30ml/min
- •Patients expected to chronically use a non-steroidal anti-inflammatory agent (except for external preparations) and those treated with a strong cytochrome P4503A4 inhibitor (eg, ketoconazole, clarithromycin, or protease inhibitors) or a strong cytochrome P450 3A4 inducer (eg, rifampicin) during the trial
结局指标
主要结局
incidence of major bleeding, non-major clinically relevant bleeding, minor bleeding events
时间窗: January 2023-December 2025
collect information of patients enrolled in this study suffered from major bleeding, non-major clinically relevant bleeding, minor bleeding events
incidence of stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack,myocardial infarction
时间窗: January 2023-December 2025
collect the information of patients enrolled in this study suffered from stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack, myocardial infarction
次要结局
未报告次要终点