Atrial Fibrillation Clinical Trial
Official title:
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.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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