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

15 января 2020 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Мерцательная аритмия

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

5000

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Boyoung Jung
Номер телефона: +82 02-2228-8447
Электронная почта: cby6908@yuhs.ac

Места учебы

Корея, Республика
- - Seoul, Корея, Республика, 03722
    - Рекрутинг
    - Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
    - Контакт:
      
      Boyoung Joung, M.D., Ph.D.
      
      Номер телефона: +82-2228-8447
      
      Электронная почта: CBY690@yuhs.ac

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

20 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Atrial fibrillatin patients taking Elxaban in general hospital

Описание

Inclusion Criteria:

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

Exclusion Criteria:

patients who do not agree with study inclusion
patients with age less than 19
Pregnancy, Breastfeeding

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
Elxaban group AF patients taking Elxaban

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
major bleeding Временное ограничение: 1 month	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or 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 Временное ограничение: 6 months	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or 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 Временное ограничение: 12 months	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or 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 Временное ограничение: 24 months	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or 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 Временное ограничение: 1 month	Stroke included both ischemic and hemorrhagic stroke.	1 month
Stroke Временное ограничение: 6 months	Stroke included both ischemic and hemorrhagic stroke.	6 months
Stroke Временное ограничение: 12 months	Stroke included both ischemic and hemorrhagic stroke.	12 months
Stroke Временное ограничение: 24 months	Stroke included both ischemic and hemorrhagic stroke.	24 months
systemic embolism Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 24 months	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	24 months
death Временное ограничение: 1 month	Death included overall death, cardiovascular death and non-cardiovascular death.	1 month
death Временное ограничение: 6 months	Death included overall death, cardiovascular death and non-cardiovascular death.	6 months
death Временное ограничение: 12 months	Death included overall death, cardiovascular death and non-cardiovascular death.	12 months
death Временное ограничение: 24 months	Death included overall death, cardiovascular death and non-cardiovascular death.	24 months

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
other clinical events: acute myocardial infarction Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 1 month	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	1 month
drug adherence Временное ограничение: 6 months	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	6 months
drug adherence Временное ограничение: 12 months	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	12 months
drug adherence Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Yonsei University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

2 января 2020 г.

Первичное завершение (Ожидаемый)

1 августа 2022 г.

Завершение исследования (Ожидаемый)

1 марта 2024 г.

Даты регистрации исследования

Первый отправленный

7 октября 2019 г.

Впервые представлено, что соответствует критериям контроля качества

11 октября 2019 г.

Первый опубликованный (Действительный)

14 октября 2019 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 января 2020 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 января 2020 г.

Последняя проверка

1 января 2020 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Elxaban

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

4-2019-0536

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .