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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657616
• Other study ID #: NOAC001
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: January 13, 2016
• Start date: December 2015

Study information

• Verified date: January 2016
• Source: Institut für Pharmakoökonomie und Arzneimittellogistik e.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: GKV Spitzenverband Bund der Krankenkassen
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204464
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke
• Stroke Prophylaxis

Intervention

Drug:
• vitamin-k-antagonists

• Novel oral anticoagulants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pharmakoökonomie und Arzneimittellogistik e.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		01/01/2011-30/06/2014; at least 12 months; up to 40 months	No
Primary	Transient ischemic attack		01/01/2011-30/06/2014; at least 12 months; up to 40 months	No
Primary	Ischemic stroke		01/01/2011-30/06/2014; at least 12 months; up to 40 months	No
Primary	Hemorrhagic stroke		01/01/2011-30/06/2014; at least 12 months; up to 40 months	Yes
Primary	Heavy bleeding		01/01/2011-30/06/2014; at least 12 months; up to 40 months	Yes