NCT02754154已完成不适用
Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
Bristol-Myers Squibb0 个研究点目标入组 321,182 人开始时间: 2014年12月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 321,182
- 主要终点
- Time to "First Major" Bleeding event
研究概览
简要总结
The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients ≥18 years old as of the index date
- •At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim
- •At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study
排除标准
- •Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date
- •Patients with any evidence of pregnancy at any time during the baseline will be excluded
研究组 & 干预措施
Patients using Warfarin
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin
干预措施: Warfarin (Drug)
Patients using Apixaban
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban
干预措施: Apixaban (Drug)
Patients using Dabigatran
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran
干预措施: Dabigatran (Drug)
Patients using Rivaroxaban
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Time to "First Major" Bleeding event
时间窗: Up to 25 months
次要结局
- Major Bleeding-Related Healthcare Utilization(Up to 25 months)
- Major Bleeding-Related direct medical cost(Up to 25 months)
- Any Bleeding-Related direct medical cost(Up to 25 months)
- Time to "First Any" Bleeding event(Up to 25 months)
- Any Bleeding-Related Healthcare Utilization(Up to 25 months)
研究者
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