NCT03189069已完成不适用
Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin
Bristol-Myers Squibb0 个研究点目标入组 36,000 人开始时间: 2016年10月6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
- 36,000
- 主要终点
- Major bleeding
研究概览
简要总结
The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with apixaban, dabigatran, rivaroxaban, or warfarin.
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
- •Had at least 1 pharmacy claim for warfarin, apixaban, dabigatran, or rivaroxaban during the identification period (01-Jan-2013 through 31-Dec-2015)
- •Had continuous health plan enrollment with medical and pharmacy benefits for 6 months pre-index date (baseline period)
- •Had continuous health plan enrollment with medical and pharmacy benefits for at least 1 month following index date
- •Had at least 1 medical claim for atrial fibrillation any time before or on index date
排除标准
- •Had medical claims with a diagnosis code for rheumatic mitral valvular heart disease, mitral valve stenosis or heart valve replacement/transplant during the 6-month baseline period
- •Had medical claims with a diagnosis code for dialysis, kidney transplant, or end-stage chronic kidney disease during the 6 month baseline period
- •Had medical claims indicating a diagnosis of venous thromboembolism during the 6-month baseline period
- •Had claims indicating a diagnosis or procedure code of hip or knee replacement surgery within 6 weeks prior to the index date
- •Had claims for a diagnosis or procedure code for reversible atrial fibrillation
- •Had medical claims indicating pregnancy during the study period
- •Had a pharmacy claim for warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban during the 6-month baseline period
- •Had > 1 oral anticoagulant prescription claim on the index date
研究组 & 干预措施
Patients prescribed apixaban
干预措施: Apixaban (Drug)
Patients prescribed dabigatran
干预措施: Dabigatran (Drug)
Patients prescribed rivaroxaban
干预措施: Rivaroxaban (Drug)
Patients prescribed warfarin
干预措施: Warfarin (Drug)
结局指标
主要结局
Major bleeding
时间窗: 36 months
次要结局
未报告次要终点
研究者
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