The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25,586
- 试验地点
- 1
- 主要终点
- Stroke (Hemorrhagic, Ischemic)
研究概览
简要总结
The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.
详细描述
Study Design:
Retrospective
研究设计
- 研究类型
- Observational
- 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
Stroke (Hemorrhagic, Ischemic)
时间窗: From October 1, 2009 through July 31, 2013 (the study period)
Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
Major Bleeding
时间窗: From October 1, 2009 through July 31, 2013 (the study period)
Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
次要结局
- Ischemic Stroke(From October 1, 2009 through July 31, 2013 (the study period))
- Hemorrhagic Stroke(From October 1, 2009 through July 31, 2013 (the study period).)
- Major Intracranial Bleeding(From October 1, 2009 through July 31, 2013 (the study period).)
- Major Extracranial Bleeding(From October 1, 2009 through July 31, 2013 (the study period).)
- Major GI Bleeding(From October 1, 2009 through July 31, 2013 (the study period).)
- Major Upper GI Bleeding(From October 1, 2009 through July 31, 2013 (the study period).)
- Major Lower GI Bleeding(From October 1, 2009 through July 31, 2013 (the study period).)
- Major Urogenital Bleeding(From October 1, 2009 through July 31, 2013 (the study period).)
- Major Other Bleeding(From October 1, 2009 through July 31, 2013 (the study period).)
- Venous Thromboembolism(From October 1, 2009 through July 31, 2013 (the study period).)
- Transient Ischemic Attack(From October 1, 2009 through July 31, 2013 (the study period).)
- Myocardial Infarction(From October 1, 2009 through July 31, 2013 (the study period).)
- Deep Vein Thrombosis(From October 1, 2009 through July 31, 2013 (the study period).)
- Pulmonary Embolism(From October 1, 2009 through July 31, 2013 (the study period).)
- Death(From October 1, 2009 through July 31, 2013 (the study period).)