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OpenTrials
Completed

NCT Number: NCT02657616

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Prophylaxis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vitamin-k-antagonists

Drug

Novel oral anticoagulants

Drug

Primary outcomes

  1. Death

    Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months

  2. Transient ischemic attack

    Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months

  3. Ischemic stroke

    Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months

  4. Hemorrhagic stroke

    Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months

  5. Heavy bleeding

    Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months

Sponsors and collaborators

Lead sponsor

Institut für Pharmakoökonomie und Arzneimittellogistik e.V.

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
First posted
Jan 18, 2016
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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