NCT02661516已完成不适用
Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-Valvular Atrial Fibrillation Treated With Vitamin K Antagonists
Bristol-Myers Squibb0 个研究点目标入组 16,513 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16,513
- 主要终点
- Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios
研究概览
简要总结
The purpose of the study is to estimate the impact of bleeding events in patients in the UK with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the CPRD-HES cohort, patients will be included if they meet these criteria:
- •Have CPRD data linked to HES
- •Have an AF diagnosis (based on Read codes from CPRD or ICD-10 codes from HES) and have been treated with VKA during the study period
- •≥18 years old at index date
- •CPRD acceptability quality criteria are present.
- •For the CPRD cohort, patients will be included if they meet the following criteria:
- •Have an Atrial Fibrillation (AF) diagnosis (based on Read codes from CPRD) and have been treated with VKAs during the study period
- •≥18 years old at index date
- •CPRD acceptability quality criteria are present.
排除标准
- •For the two cohorts of interest, patients will be excluded if they meet the following criteria:
- •Fewer than 12 months of computerised data available prior to the index date (in order to provide a minimum amount of computerised history and to avoid issues associated with updating records when a patient joins a practice). The date of start of computerized records will be the latter of the patient's date of registration with the practice or the practice's Up-to-Standard (UTS) date (when the practice is deemed to be contributing data of adequate quality)
- •The practice is not UTS, or the patient is deemed "unacceptable" according to CPRD's quality criteria
- •There is evidence of valvular disease, repair, or replacement before (ie, up to 12 months prior to the index date) or during the study period
- •There are records of Novel anticoagulant (NOAC)
结局指标
主要结局
Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios
时间窗: Up to 24 months after initial treatment with VKA
Impact of bleeding events on the rate of health-care resource utilization (HCRU) assessed based on incidence rate ratios
时间窗: Up to 24 months after initial treatment with VKA
Impact of bleeding events on the health-care costs in NVAF patients treated by VKAs assessed based on ratios of costs associated with number of bleeding events
时间窗: Up to 24 months after initial treatment with VKA
次要结局
- Characteristics of NVAF patients newly treated with VKA who experience bleeding events(Up to 24 months after initial treatment with VKA)
- Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events(Up to 24 months after initial treatment with VKA)
- Variation of impact of bleeding events on clinical events, the rate of HCRU, and health-care costs over time following each bleeding event in NVAF patients treated by VKA(Upto 24 months after initial treatment with VKA)
研究者
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