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Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment

5 de mayo de 2022 actualizado por: Pfizer

Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment

To describe the direct costs related to warfarin/apixaban treatment

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.

Tipo de estudio

De observación

Inscripción (Actual)

109

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

  • Chequia
      • Praha 5, Chequia, 150 06
        • Fakultni nemocnice Motol

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, MAYOR_ADULTO)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.

Descripción

Inclusion Criteria:

  • Diagnosis of non-valvular atrial fibrillation (NVAF);
  • New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
  • Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
  • Apixaban arm: genetically determined higher sensitivity to warfarin;
  • Patients whose status allowed oral treatment with apixaban/warfarin;
  • Age ≥ 18;
  • Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.

Exclusion Criteria:

  • Diagnosis of valvular disease;
  • Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
  • Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
  • Contraindications according SmPC of Eliquis

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
Non-valvular Atrial Fibrillation (NVAF) on warfarin
The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.
Non-valvular Atrial Fibrillation (NVAF) on apixaban
The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Puntuación CHA2-DS2-VASc al inicio
Periodo de tiempo: Línea de base (a partir de datos retrospectivos recuperados en el estudio)
Se utilizó la escala de puntuación CHA2DS2-VASc para estimar el riesgo de accidente cerebrovascular y embolia sistémica en participantes con FANV. La puntuación CHA2DS2-VASc se calculó en función de 8 factores de riesgo (edad 65-74 años, edad >=75 años, categoría de sexo, es decir, sexo femenino, antecedentes de insuficiencia cardíaca congestiva, antecedentes de hipertensión, antecedentes de accidente cerebrovascular/AIT/tromboembolismo, antecedentes de enfermedad vascular y antecedentes de diabetes mellitus). La puntuación total de CHA2DS2-VASc osciló entre 0 y 9, donde 0 = bajo riesgo y 9 = alto riesgo de accidente cerebrovascular.
Línea de base (a partir de datos retrospectivos recuperados en el estudio)
HAS-BLED Score at Baseline
Periodo de tiempo: Baseline (from retrospective data retrieved in the study)
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
Baseline (from retrospective data retrieved in the study)
CHA2-DS2-VASc Score at Month 6
Periodo de tiempo: Month 6 (from retrospective data retrieved in the study)
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Month 6 (from retrospective data retrieved in the study)
HAS-BLED Score at Month 6
Periodo de tiempo: Month 6 (from retrospective data retrieved in the study)
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
Month 6 (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Outpatient Visits During First 6 Months of Treatment
Periodo de tiempo: Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
Los costos de las visitas ambulatorias se calcularon para los primeros 6 meses de tratamiento como el número de visitas multiplicado por el costo de la visita (450,0 Corona checa [CZK] por visita). Los costes se calcularon en función del número de visitas ambulatorias durante el tratamiento.
Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
Periodo de tiempo: Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (>=) 20.
Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
Cost of INR Measurements During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Dosage of Warfarin and Apixaban at the Initiation of the Treatment
Periodo de tiempo: Línea de base (a partir de datos retrospectivos recuperados en el estudio)
In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.
Línea de base (a partir de datos retrospectivos recuperados en el estudio)
Dosage of Warfarin and Apixaban During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Medication During First 6 Months of Treatment
Periodo de tiempo: Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.
Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
Percentage of Participants Categorized According to Number of Hospital Admissions
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Hospital Admissions During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Diagnostic Procedures
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Porcentaje de participantes clasificados según el tipo de eventos isquémicos durante los primeros 6 meses de tratamiento
Periodo de tiempo: Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
En esta medida de resultado, el porcentaje de participantes se clasificó según el tipo de eventos isquémicos que incluyeron isquemia cardíaca y accidente cerebrovascular/AIT.
Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
Cost of Ischemic Events During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
Periodo de tiempo: Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.
Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Major Hemorrhagic Events During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Number of Participants With Other Adverse Events During First 6 Months of Treatment
Periodo de tiempo: Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.
Hasta los primeros 6 meses de tratamiento (a partir de datos retrospectivos recuperados en el estudio)
Cost of Other Adverse Events During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
Periodo de tiempo: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants who died due to the given treatment were reported.
Up to first 6 months of treatment (from retrospective data retrieved in the study)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

4 de agosto de 2020

Finalización primaria (ACTUAL)

31 de mayo de 2021

Finalización del estudio (ACTUAL)

31 de mayo de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2020

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2020

Publicado por primera vez (ACTUAL)

17 de junio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (ACTUAL)

8 de febrero de 2023

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • B0661121
  • APIXABAN SECOND LINE (OTRO: Alias Study Number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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. .

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