NCT02153424撤回不适用
Early Post-marketing Study of Eliquis (Apixaban)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Identify, describe, and report any suspected AEs that occur while on treatment with Apixaban or preventing stroke and systemic embolism in patients with NVAF
研究概览
简要总结
The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period
排除标准
- •Subjects who received Apixaban as part of a clinical trial
- •Subjects who received Apixaban for any indication other than local approval (ie, to reduce the risk of stroke and systemic embolism in patients with NVAF)
研究组 & 干预措施
NVAF patients in Mexico treated with Apixaban
All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period
干预措施: Apixaban (Drug)
结局指标
主要结局
Identify, describe, and report any suspected AEs that occur while on treatment with Apixaban or preventing stroke and systemic embolism in patients with NVAF
时间窗: Up to 24 months
Determine the reporting rate of on-treatment adverse events (AEs) by the treating physicians
时间窗: Up to 24 month study period
次要结局
未报告次要终点
研究者
研究点 (1)
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