Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA
Stroke Prophylaxis of Patients With Atrial Fibrillation: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to Vitamin-k-antagonists Based on an Analysis of German Claims Data
The central questions of the study can be summarized as follows:
What stroke / death rates are the result of the use of the following treatment strategies: no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs), anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic complication rates resulting from the use of these treatment strategies? What heavy bleeding rates resulting from the defined management strategies? The analysis is based on a data set of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation time per patient is 12 months.
Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.
The aim of the study is to compare clinical outcomes between the different treatment strategies (frequency of events and time to first event). The influence of alternative treatment strategies is measured on the basis of three different methodological approaches: unadjusted comparison of event council and time to first event between the defined patient groups; matched-pair comparison (propensity score matching) between the different groups of patients (treatment strategies) and multivariate analysis using time to event (Cox proportional hazards model) as the dependent variable.
研究概览
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- one inpatient or two outpatient confirmed diagnosis of atrial fibrillation in two different quarters
- Continuously insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg
Exclusion Criteria:
- Age < 18 years
- Maximum possible observational period < 12 months (exception: death)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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No anticoagulation with VKA/NOAC
No prescriptions of vitamin-k-antagonists/novel anticoagulants in all observational period; No prescriptions of low molecular weight heparins/Clopidogrel during observation period to the extent of more than 30 days.
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Anticoagulation with vitamin-k-antagonists
The patient should be treated stable during the observation period with vitamin-k-antagonists (at least one prescription per half-year).
The patient should be not been around on other anticoagulants during the observation period.
This means that no prescriptions of novel anticoagulants and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year.
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Anticoagulation with novel oral anticoagulants
The patient should be treated stable during the observation period with a novel anticoagulant (at least one prescription per half-year).
This means that no vitamin-k-antagonists prescriptions and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year from the start of the observation period.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Death
大体时间：01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Transient ischemic attack
大体时间：01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Ischemic stroke
大体时间：01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Hemorrhagic stroke
大体时间：01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Heavy bleeding
大体时间：01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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