APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 321,501
- 主要终点
- Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure
研究概览
简要总结
The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base).
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
- •Patient meeting inclusion criteria of the French Système national d'information inter-régimes de l'assurance maladie (SNIIR-AM)/Programme de médicalisation des systèmes d'information (PMSI) claim databases (Patient insured by the French national health insurance general scheme stricto sensu (apart from local mutualist sections)
- •Patients with at least one reimbursement of AC treatment (acenocoumarol, warfarine and fluidione for VKA treatments, apixaban, dabigatran or rivaroxaban for New oral anticoagulants (NOACs)) treatments during the inclusion period
- •Patients initiated with a new AC treatment during the inclusion period, either AC naive or not
- •Patients aged 18 or older at their first anticoagulant initiation during the inclusion period
- •Patient diagnosed with non-valvular Atrial fibrillation (AF)
排除标准
- 未提供
研究组 & 干预措施
AC-naive treated with VKA
AC-naive treated with VKA
干预措施: VKA (Drug)
AC-naive treated with apixaban
AC-naive treated with apixaban
干预措施: Apixaban (Drug)
AC-naive treated with dabigatran
AC-naive treated with dabigatran
干预措施: dabigatran (Drug)
AC-naive treated with rivaroxaban
AC-naive treated with rivaroxaban
干预措施: rivaroxaban (Drug)
AC-experienced treated with VKA
AC-experienced treated with VKA
干预措施: VKA (Drug)
AC-experienced treated with apixaban
AC-experienced treated with apixaban
干预措施: Apixaban (Drug)
AC-experienced treated with dabigatran
AC-experienced treated with dabigatran
干预措施: dabigatran (Drug)
AC-experienced treated with rivaroxaban
AC-experienced treated with rivaroxaban
干预措施: rivaroxaban (Drug)
结局指标
主要结局
Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure
时间窗: Approximately 2 years
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Incidence rate (95%CI) of first event of stroke and/or systemic embolism (effectiveness) and of first event of major bleeding (safety) over the period of AC ex
Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator
时间窗: Approximately 2 years
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Time-to-first occurrence of stroke and/or systemic embolism (effectiveness) and of major bleedings (safety) using Kaplan-Meier product limit estimator (95%CI)
次要结局
- The healthcare resources utilization will be described by AC treatment(Approximately 2 years)
- Incidence rates for composite morbidity criterion and all-cause death over the period of AC exposure will be estimated by AC treatment(Approximately 2 years)
- Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI)(Approximately 2 years)
- Comparisons of major characteristics of patients between apixaban and each of the other AC treatments(Approximately 2 years)
- Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator(Approximately 2 years)
- Major characteristics of patients will be described by AC treatments(Approximately 2 years)
- Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment(Approximately 2 years)
- Comparison of incidence rates of each studied event (stroke or systemic thromboembolic event, major bleeding, all-cause death) between apixaban and each of the other usual AC treatments(Approximately 2 years)
- Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments(Approximately 2 years)