Clinical trial NCT02657616: Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke Prophylaxis
Lead sponsor: Institut für Pharmakoökonomie und Arzneimittellogistik e.V.
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 204464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The analysis is based on a data set of patients with atrial fibrillation (01/01/2010 - 30/06/2014) insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Death
timeFrame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
measure: Transient ischemic attack
timeFrame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
measure: Ischemic stroke
timeFrame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
measure: Hemorrhagic stroke
timeFrame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
measure: Heavy bleeding
timeFrame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.