Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA

Completed

• Conditions: Atrial Fibrillation; Stroke Prophylaxis
• Interventions: Drug: vitamin-k-antagonists; Drug: Novel oral anticoagulants

• Registration Number: NCT02657616
• Lead Sponsor: Institut für Pharmakoökonomie und Arzneimittellogistik e.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-13
• Last Update Submitted: 2016-01-13
• Study First Posted: 2016-01-18
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204464

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anticoagulation with vitamin-k-antagonists	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.
Anticoagulation with novel oral anticoagulants	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.

Primary Outcome Measures

Name	Time	Method
Death	01/01/2011-30/06/2014; at least 12 months; up to 40 months
Transient ischemic attack	01/01/2011-30/06/2014; at least 12 months; up to 40 months
Ischemic stroke	01/01/2011-30/06/2014; at least 12 months; up to 40 months
Hemorrhagic stroke	01/01/2011-30/06/2014; at least 12 months; up to 40 months
Heavy bleeding	01/01/2011-30/06/2014; at least 12 months; up to 40 months