Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data

Bristol-Myers Squibb0 个研究点开始时间: 2016年1月31日最近更新: 2018年10月10日

适应症

试验速览

阶段: 不适用
状态: 撤回
发起方
主要终点: Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.

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

•Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period
•Are ≥ 18 years of age at index date
•Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation)
•Have a record of AF on or ever prior to index date

排除标准

•Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
•Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA)
•Have more than 1 OAC exposure which starts on the same date

结局指标

主要结局

Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

时间窗: Approximately 3 years

次要结局

Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)(Approximately 3 years)
Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)(At baseline)
Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)(At baseline)
Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)(Approximately 3 years)
Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)(Approximately 3 years)

研究者

发起方

Bristol-Myers Squibb

申办方类型

Industry

责任方

Sponsor

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