The Effectiveness and Safety of Apixaban Versus Warfarin in Non-valvular Atrial Fibrillation (NVAF) Patients With the History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 1
- 主要终点
- Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism
研究概览
简要总结
Old age, less body weight and deteriorated renal function are significant clinical factors for the outcomes of atrial fibrillation- so called 'fragile'- and these are common risk factors in osteoporosis and fracture. Therefore, in real world, these risk factors and co-morbidities are commonly considered when it comes to prescribe anticoagulant in atrial fibrillation patients. Recent study even reported that comorbid atrial fibrillation in patients with osteoporosis might be associated with an increased risk of bone fracture and death after fracture. Because there have been very few data about the effectiveness/safety of anticoagulant among non-valvular atrial fibrillation with prior osteoporosis/fracture, this study is planned to provide real-world evidences for this specific type of non-valvular atrial fibrillation patients.
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 aged 18 years or older on the index date
- •Patients had ≥1 medical claim for atrial fibrillation with at least one hospitalization or at least two outpatient visits during the reference period
排除标准
- •Patients with valvular atrial fibrillation or transient atrial fibrillation
- •Having ≥ 2 types of oral anticoagulant on the index date
- •who have contraindications to oral anticoagulant
- •confounder factors related to the outcome (osteoporotic fractures)
研究组 & 干预措施
Warfarin user
干预措施: warfarin (Drug)
Apixaban user
干预措施: apixaban (Drug)
结局指标
主要结局
Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism
时间窗: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period(the index date- Nov 30, 2016 or outcomes whichever comes first)
Intake period is from July 1, 2015 to Nov 30, 2016.
次要结局
- Major bleeding including gastrointestinal bleeding, intracranial bleeding, and other bleeding(from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period (the index date- Nov 30, 2016 or outcomes whichever comes first))