Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,739
- 试验地点
- 1
- 主要终点
- Time period from OAC discontinuation to ischemic stroke for NVAF patients
研究概览
简要总结
This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial fibrillation) in a UK general population using The Health Improvement Network (THIN) database.
The main aim of the study is to estimate in how many patients atrial fibrillation was diagnosed at the moment of stroke and to describe whether these patients received OAC at the time of the stroke. In addition, researchers want to learn about the relative risk of ischemic stroke when such patients did not continue OAC treatment.
详细描述
The primary objectives of the study are to determine the incidence of ischemic stroke in patients registered in the British primary care THIN database and to investigate the OAC exposure, OAC treatment patterns and the relative risk of having an ischemic stroke in relation to OAC treatment for a subgroup of patients, who were diagnosed with non-valvular atrial fibrillation (NVAF) prior to ischemic stroke.
Secondary objectives are to determine the number of patients having NVAF diagnosed at the time of ischemic stroke and within 1 and 12 months after ischemic stroke; to describe cardiovascular risk factors for ischemic stroke and pharmacological treatments before and 12 months after ischemic stroke, and to estimate the case-fatality at 1 and 12 months after the occurrence of 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
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Occurrence of an ischemic stroke that lead to hospitalization between 01-Jul-2016 to 30-Jun-2018 and concerned adults registered in the THIN database
- •Subgroup: Patients with diagnosed NVAF prior or at the time of ischemic stroke
排除标准
- 未提供
研究组 & 干预措施
Subjects with ischemic stroke
Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018
干预措施: Oral anticoagulant (Drug)
NVAF patients with ischemic stroke
Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018 and had a diagnosis of NVAF prior to ischemic stroke (Subgroup)
干预措施: Oral anticoagulant (Drug)
结局指标
主要结局
Time period from OAC discontinuation to ischemic stroke for NVAF patients
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke after OAC discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Number of subjects with ischemic stroke
时间窗: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
Number of NVAF patients with OAC prescription prior to ischemic stroke
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Duration of OAC treatment before OAC discontinuation for NVAF patients
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke by OAC treatment duration before OAC discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke by VKA treatment duration before VKA discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Incidence of ischemic stroke
时间窗: Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018
Relative risk of NVAF patients for ischemic stroke by time since OAC discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke by time since VKA discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke after NOAC discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke after VKA discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke by time since NOAC discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
Relative risk of NVAF patients for ischemic stroke by NOAC treatment duration before NOAC discontinuation
时间窗: Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018
For NVAF subgroup only
次要结局
- Prevalence of cardiovascular co-morbidities one year before ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Case-fatality of patients with unknown NVAF diagnosis at 12 months after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Number of subjects with first diagnosis of NVAF within 1 month after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jul-2018)
- Number of subjects with first diagnosis of NVAF within 12 months after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months before ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Case-fatality of patients with unknown NVAF diagnosis at 1 month after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Number of subjects with first diagnosis of NVAF at time of ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018)
- Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months before ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Case-fatality of patients with known NVAF diagnosis at 1 month after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)
- Case-fatality for patients with known NVAF diagnosis at 12 months after ischemic stroke(Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019)