Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221,228
- 试验地点
- 1
- 主要终点
- Major Bleeding
研究概览
简要总结
This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Major Bleeding
时间窗: From October 2010 to September 2015 (the study period)
The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).
Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification)
时间窗: From October 2010 to September 2015 (the study period)
The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events.
次要结局
- Ischemic Stroke(From October 2010 to September 2015 (the study period))
- Systemic Embolism(From October 2010 to September 2015 (the study period))
- Other Major Bleeding(From October 2010 to September 2015 (the study period))
- Hemorrhagic Stroke(From October 2010 to September 2015 (the study period))
- Major Extra-cranial Bleeding(From October 2010 to September 2015 (the study period))
- Stroke or Systemic Embolism(From October 2010 to September 2015 (the study period))
- Stroke Uncertain Classification(From October 2010 to September 2015 (the study period))
- Major Intracranial Bleeding(From October 2010 to September 2015 (the study period))
- Major Gastrointestinal (GI) Bleeding(From October 2010 to September 2015 (the study period))
- Major Upper Gastrointestinal Bleeding(From October 2010 to September 2015 (the study period))
- Major Lower Gastrointestinal Bleeding(From October 2010 to September 2015 (the study period))
- Pulmonary Embolism (PE)(From October 2010 to September 2015 (the study period))
- Major Urogenital Bleeding(From October 2010 to September 2015 (the study period))
- Transient Ischemic Attack (TIA)(From October 2010 to September 2015 (the study period))
- Deep Vein Thrombosis (DVT)(From October 2010 to September 2015 (the study period))
- Myocardial Infarction (MI)(From October 2010 to September 2015 (the study period))
- Venous Thromboembolism (VTE)(From October 2010 to September 2015 (the study period))