Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 45,164
- 试验地点
- 1
- 主要终点
- Risk of intracranial hemorrhage
研究概览
简要总结
This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as treatment for Stroke Prevention in Atrial Fibrillation (SPAF). Purpose of the study is to learn more about the safety and how well the drugs rivaroxaban, apixaban and warfarin work in patients appropriately and inappropriately receiving standard and reduced doses of each drug for reducing the risk of stroke in atrial fibrillation. Real world data from routine general practice stored in the primary care database in the UK, The Health Improvement Network (THIN), will be used for investigation.
详细描述
Primary objectives are to assess the safety and effectiveness of rivaroxaban, apixaban and warfarin based on the risk of intracranial hemorrhage and hemorrhagic strokes (safety) and ischemic stroke, systemic embolism and myocardial infarction (effectiveness). Secondary objectives comprise the assessment of the mentioned risks in subpopulations of patients with renal impairment or diabetes, mortality rates, and drug utilisation as well as patient characteristics before and after the first intracranial hemorrhage or ischemic 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
- •Patients with non-valvular atrial fibrillation
- •New users of rivaroxaban, apixaban or warfarin
- •At least one year enrollment with the general practice (GP)
- •One year since first health contact recorded in THIN prior to the first prescription of a study drug
排除标准
- •Patients with other recent indications of oral anticoagulant initiation
- •Individuals on more than one oral anticoagulant on the start date
- •Users of rivaroxaban apart from 15 / 20 mg daily dose
- •Users of apixaban apart from 5 / 10 mg daily dose
研究组 & 干预措施
NVAF-patients_1
Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
NVAF-patients_2
Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.
干预措施: Apixaban (Eliquis) (Drug)
NVAF-patients_3
Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.
干预措施: Warfarin (Drug)
结局指标
主要结局
Risk of intracranial hemorrhage
时间窗: Retrospective analysis of data from 2012 to 2017
Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Risk of ischemic events
时间窗: Retrospective analysis of data from 2012 to 2017
Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.
次要结局
- Risk of intracranial hemorrhage in NVAF-patients with renal impairment(Retrospective analysis of data from 2012 to 2017)
- Risk of ischemic events in NVAF-patients with renal impairment(Retrospective analysis of data from 2012 to 2017)
- Risk of intracranial hemorrhage in NVAF-patients with diabetes(Retrospective analysis of data from 2012 to 2017)
- Risk of ischemic events in NVAF-patients with diabetes(Retrospective analysis of data from 2012 to 2017)
- Drug utilisation(Retrospective analysis of data from 2012 to 2017)
- Drug utilisation after first intracranial hemorrhage or ischemic stroke(Retrospective analysis of data from 2012 to 2017)
- All-cause mortality(Retrospective analysis of data from 2012 to 2017)
- Patient characteristics(Retrospective analysis of data from 2012 to 2017)
- Patient characteristics after first intracranial hemorrhage or ischemic stroke(Retrospective analysis of data from 2012 to 2017)