Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA
NCT ID: NCT02657616
Last Updated: 2016-01-18
Study Results
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Basic Information
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COMPLETED
204464 participants
OBSERVATIONAL
2015-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
vitamin-k-antagonists
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.
Novel oral anticoagulants
Interventions
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vitamin-k-antagonists
Novel oral anticoagulants
Eligibility Criteria
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Inclusion Criteria
* Continuously insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg
Exclusion Criteria
* Maximum possible observational period \< 12 months (exception: death)
18 Years
ALL
No
Sponsors
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Institut für Pharmakoökonomie und Arzneimittellogistik e.V.
OTHER
Responsible Party
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Sabrina Müller
Principal investigator
References
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Mueller S, Groth A, Spitzer SG, Schramm A, Pfaff A, Maywald U. Real-world effectiveness and safety of oral anticoagulation strategies in atrial fibrillation: a cohort study based on a German claims dataset. Pragmat Obs Res. 2018 May 1;9:1-10. doi: 10.2147/POR.S156521. eCollection 2018.
Other Identifiers
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NOAC001
Identifier Type: -
Identifier Source: org_study_id
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