NCT03508271已完成不适用
Real-World Comparative Effectiveness Research Among Elderly Non-valvular Atrial Fibrillation (NVAF) Patients With Heart Failure (HF) Using Oral Anticoagulants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 2017年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60,000
- 试验地点
- 1
- 主要终点
- Incidence of stroke/systemic embolism (SE)
研究概览
简要总结
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Were age greater than or equal to 65 years as of the index date
- •Had greater than or equal to 1 diagnosis of AF prior to or on the index date
- •Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date
- •Had 1 or more pharmacy claim for oral blood thinners
排除标准
- •Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
- •Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period
- •Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day
- •Had medical claim indicating VTE in the 12 months prior to index date
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of stroke/systemic embolism (SE)
时间窗: Approximately 195 weeks
Incidence of major bleeding
时间窗: Approximately 195 weeks
次要结局
- Incidence of all cause hospitalization(Approximately 195 weeks)
- Incidence of major adverse cardiac event(Approximately 195 weeks)
- Incidence of miocardial infarction (MI)(Approximately 195 weeks)
- Incidence of all cause mortality(Approximately 195 weeks)
研究者
研究点 (1)
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