Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA
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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
|
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.
|
|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Death
Periodo de tiempo: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Transient ischemic attack
Periodo de tiempo: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Ischemic stroke
Periodo de tiempo: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Hemorrhagic stroke
Periodo de tiempo: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Heavy bleeding
Periodo de tiempo: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Arritmias Cardiacas
- Carrera
- Fibrilación auricular
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes moduladores de fibrina
- Micronutrientes
- Vitaminas
- Agentes antifibrinolíticos
- Hemostáticos
- Coagulantes
- Vitamina K
- Anticoagulantes
Otros números de identificación del estudio
- NOAC001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .