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Non-Interventional Study on Effectiveness of Elxaban Tab. in Patients With Non-valvular Atrial Fibrillation

15 de enero de 2020 actualizado por: Yonsei University
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients with atrial fibrillation taking Elxaban (generic drug of apixaban) who visit hospital. The purpose is to analyze bleeding (major bleeding, minor bleeding), stroke, systemic embolism, death, other clinical events (acute myocardial infarction, pulmonary embolism, transient ischemic attack, hospitalization), drug adherence, questionnaire of life quality (AFEQT), cognitive function (KDSQ) according to the use of Elxaban.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Tipo de estudio

De observación

Inscripción (Anticipado)

5000

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.

Estudio Contacto

  • Nombre: Boyoung Jung
  • Número de teléfono: +82 02-2228-8447
  • Correo electrónico: cby6908@yuhs.ac

Ubicaciones de estudio

  • Corea, república de
      • Seoul, Corea, república de, 03722
        • Reclutamiento
        • Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
        • Contacto:
          • Boyoung Joung, M.D., Ph.D.
          • Número de teléfono: +82-2228-8447
          • Correo electrónico: CBY690@yuhs.ac

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

20 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

Atrial fibrillatin patients taking Elxaban in general hospital

Descripción

Inclusion Criteria:

  1. patients with atrial fibrillation taking Elxaban (patients with age more than 19)
  2. Patients who agree with study inclusion

Exclusion Criteria:

  1. patients who do not agree with study inclusion
  2. patients with age less than 19
  3. Pregnancy, Breastfeeding

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
Elxaban group
AF patients taking Elxaban

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
major bleeding
Periodo de tiempo: 1 month

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
1 month
major bleeding
Periodo de tiempo: 6 months

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
6 months
major bleeding
Periodo de tiempo: 12 months

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
12 months
major bleeding
Periodo de tiempo: 24 months

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
24 months
Stroke
Periodo de tiempo: 1 month
Stroke included both ischemic and hemorrhagic stroke.
1 month
Stroke
Periodo de tiempo: 6 months
Stroke included both ischemic and hemorrhagic stroke.
6 months
Stroke
Periodo de tiempo: 12 months
Stroke included both ischemic and hemorrhagic stroke.
12 months
Stroke
Periodo de tiempo: 24 months
Stroke included both ischemic and hemorrhagic stroke.
24 months
systemic embolism
Periodo de tiempo: 1 month
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
1 month
systemic embolism
Periodo de tiempo: 6 months
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
6 months
systemic embolism
Periodo de tiempo: 12 months
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
12 months
systemic embolism
Periodo de tiempo: 24 months
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
24 months
death
Periodo de tiempo: 1 month
Death included overall death, cardiovascular death and non-cardiovascular death.
1 month
death
Periodo de tiempo: 6 months
Death included overall death, cardiovascular death and non-cardiovascular death.
6 months
death
Periodo de tiempo: 12 months
Death included overall death, cardiovascular death and non-cardiovascular death.
12 months
death
Periodo de tiempo: 24 months
Death included overall death, cardiovascular death and non-cardiovascular death.
24 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
other clinical events: acute myocardial infarction
Periodo de tiempo: 1 month
Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
1 month
other clinical events: acute myocardial infarction
Periodo de tiempo: 6 months
Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
6 months
other clinical events: acute myocardial infarction
Periodo de tiempo: 12 months
Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
12 months
other clinical events: acute myocardial infarction
Periodo de tiempo: 24 months
Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
24 months
other clinical events: pulmonary embolism
Periodo de tiempo: 1 month
Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.
1 month
other clinical events: pulmonary embolism
Periodo de tiempo: 6 months
Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.
6 months
other clinical events: pulmonary embolism
Periodo de tiempo: 12 months
Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.
12 months
other clinical events: pulmonary embolism
Periodo de tiempo: 24 months
Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.
24 months
other clinical events: transient ischemic attack
Periodo de tiempo: 1 month
Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.
1 month
other clinical events: transient ischemic attack
Periodo de tiempo: 6 months
Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.
6 months
other clinical events: transient ischemic attack
Periodo de tiempo: 12 months
Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.
12 months
other clinical events: transient ischemic attack
Periodo de tiempo: 24 months
Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.
24 months
drug adherence
Periodo de tiempo: 1 month
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
1 month
drug adherence
Periodo de tiempo: 6 months
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
6 months
drug adherence
Periodo de tiempo: 12 months
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
12 months
drug adherence
Periodo de tiempo: 24 months
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
24 months
questionnaire of life quality (AFEQT)
Periodo de tiempo: 1 month

AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains

  • Symptoms - Four questions specifically targeted to assess AF related symptoms
  • Daily Activities - Eight questions that evaluate daily function in AF patients

  • Treatment Concerns - Six questions that assess AF treatment concerns in patients

    • Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)
1 month
questionnaire of life quality (AFEQT)
Periodo de tiempo: 6 months

AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains

  • Symptoms - Four questions specifically targeted to assess AF related symptoms
  • Daily Activities - Eight questions that evaluate daily function in AF patients

  • Treatment Concerns - Six questions that assess AF treatment concerns in patients

    • Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)
6 months
questionnaire of life quality (AFEQT)
Periodo de tiempo: 12 months

AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains

  • Symptoms - Four questions specifically targeted to assess AF related symptoms
  • Daily Activities - Eight questions that evaluate daily function in AF patients

  • Treatment Concerns - Six questions that assess AF treatment concerns in patients

    • Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)
12 months
questionnaire of life quality (AFEQT)
Periodo de tiempo: 24 months

AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains

  • Symptoms - Four questions specifically targeted to assess AF related symptoms
  • Daily Activities - Eight questions that evaluate daily function in AF patients

  • Treatment Concerns - Six questions that assess AF treatment concerns in patients

    • Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)
24 months
cognitive function (KDSQ)
Periodo de tiempo: 1 month
The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.
1 month
cognitive function (KDSQ)
Periodo de tiempo: 6 months
The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.
6 months
cognitive function (KDSQ)
Periodo de tiempo: 12 months
The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.
12 months
cognitive function (KDSQ)
Periodo de tiempo: 24 months
The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.
24 months

Colaboradores e Investigadores

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

Patrocinador

Yonsei University

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)

2 de enero de 2020

Finalización primaria (Anticipado)

1 de agosto de 2022

Finalización del estudio (Anticipado)

1 de marzo de 2024

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2019

Primero enviado que cumplió con los criterios de control de calidad

11 de octubre de 2019

Publicado por primera vez (Actual)

14 de octubre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de enero de 2020

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

15 de enero de 2020

Última verificación

1 de enero de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 4-2019-0536

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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