ANTICOAGULANT TREATMENT PATTERNS AND OUTCOMES AMONG NON-VALVULAR ATRIAL FIBRILLATION PATIENTS WITH HIGH RISK OF GASTROINTESTINAL BLEEDING IN FRANCE: A RETROSPECTIVE COHORT ANALYSIS USING SNDS DATABASE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Bleeding leading to hospitalization
研究概览
简要总结
This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF with high risk of gastrointestinal bleed who initiate anticoagulant treatment with a Vitamin-K Antagonists (VKAs) or direct-acting oral anticoagulants (DOACs).
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 covered by the French national health insurance general scheme With at least one reimbursement of AC treatment (apixaban, rivaroxaban, dabigatran, or VKAs) Aged ≥18 years as of the index date With a diagnosis of atrial fibrillation (AF) prior to or on the index date With at least one risk factor for gastrointestinal bleeding
排除标准
- •Patients with different types of AC treatment at the index date Patients with a diagnosis or procedure code indicative of rheumatic mitral valvular heart disease or valve replacement procedure Individuals with a diagnosis of VTE during the 12 months prior to or on the index date
研究组 & 干预措施
NVAF High GI bleed risk
NVAF patients with a high risk of gastrointestinal bleeding
干预措施: Dabigatran (Drug)
NVAF High GI bleed risk
NVAF patients with a high risk of gastrointestinal bleeding
干预措施: Vitamin K antagonist (VKA) (Drug)
NVAF High GI bleed risk
NVAF patients with a high risk of gastrointestinal bleeding
干预措施: Apixaban (Drug)
NVAF High GI bleed risk
NVAF patients with a high risk of gastrointestinal bleeding
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Bleeding leading to hospitalization
时间窗: 2016-2019
The follow-up period will be from the index date to death or end of study (31 December 2019). For the comparative analyses of clinical outcomes the follow-up period will be from the day after index date to the earliest of an outcome of interest (separately for each outcome); treatment discontinuation, treatment switch, death, or end of study.
Stroke
时间窗: 2016-2019
The follow-up period will be from the index date to death or end of study (31 December 2019). For the comparative analyses of clinical outcomes the follow-up period will be from the index date to the earliest of an outcome of interest (separately for each outcome); treatment discontinuation, treatment switch, death, or end of study.
次要结局
未报告次要终点