Anticoagulant Utilization Pattern
26 de marzo de 2019 actualizado por: Boehringer Ingelheim
A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation
This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
333664
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02120
- Brigham and Women's Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation
Descripción
Inclusion criteria:
- A recorded diagnosis of atrial fibrillation
- Initiation of oral anticoagulant medication
- Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score >=1
- At least 18 years of age on the date of anticoagulant initiation
Exclusion criteria:
- Patients with missing or ambiguous age or sex information
- Patients with documented evidence of valvular disease
- Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing
- Patients with prior use of any oral anticoagulant
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Dabigatrán
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Warfarin or other New Oral Anticoagulant (NOAC)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Description of the Characteristics of Anticoagulant Initiators
Periodo de tiempo: From January 2009 to September 2015 (The study period)
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The analyses described the characteristics of patients treated with various oral anticoagulants.
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender.
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant
Periodo de tiempo: From January 2009 to September 2015 (The study period)
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Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users.
The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm.
Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm.
Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
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From January 2009 to September 2015 (The study period)
|
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Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
Periodo de tiempo: From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
Periodo de tiempo: From January 2009 to September 2015 (The study period)
|
Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
Periodo de tiempo: From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment Persistence Over Time
Periodo de tiempo: From January 2009 to September 2015 (The study period)
|
Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort.
Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.
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From January 2009 to September 2015 (The study period)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de abril de 2013
Finalización primaria (Actual)
1 de noviembre de 2017
Finalización del estudio (Actual)
1 de noviembre de 2017
Fechas de registro del estudio
Enviado por primera vez
18 de abril de 2013
Primero enviado que cumplió con los criterios de control de calidad
2 de mayo de 2013
Publicado por primera vez (Estimar)
7 de mayo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
26 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1160.177
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