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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGmajor bleeding
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.
Time frame: 1 month
major bleeding
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.
Time frame: 6 months
major bleeding
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.
Time frame: 12 months
major bleeding
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.
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Time frame: 24 months
Stroke
Stroke included both ischemic and hemorrhagic stroke.
Time frame: 1 month
Stroke
Stroke included both ischemic and hemorrhagic stroke.
Time frame: 6 months
Stroke
Stroke included both ischemic and hemorrhagic stroke.
Time frame: 12 months
Stroke
Stroke included both ischemic and hemorrhagic stroke.
Time frame: 24 months
systemic embolism
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
Time frame: 1 month
systemic embolism
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
Time frame: 6 months
systemic embolism
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
Time frame: 12 months
systemic embolism
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
Time frame: 24 months
death
Death included overall death, cardiovascular death and non-cardiovascular death.
Time frame: 1 month
death
Death included overall death, cardiovascular death and non-cardiovascular death.
Time frame: 6 months
death
Death included overall death, cardiovascular death and non-cardiovascular death.
Time frame: 12 months
death
Death included overall death, cardiovascular death and non-cardiovascular death.
Time frame: 24 months
other clinical events: acute myocardial infarction
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.
Time frame: 1 month
other clinical events: acute myocardial infarction
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.
Time frame: 6 months
other clinical events: acute myocardial infarction
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.
Time frame: 12 months
other clinical events: acute myocardial infarction
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.
Time frame: 24 months
other clinical events: pulmonary embolism
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.
Time frame: 1 month
other clinical events: pulmonary embolism
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.
Time frame: 6 months
other clinical events: pulmonary embolism
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.
Time frame: 12 months
other clinical events: pulmonary embolism
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.
Time frame: 24 months
other clinical events: transient ischemic attack
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.
Time frame: 1 month
other clinical events: transient ischemic attack
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.
Time frame: 6 months
other clinical events: transient ischemic attack
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.
Time frame: 12 months
other clinical events: transient ischemic attack
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.
Time frame: 24 months
drug adherence
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
Time frame: 1 month
drug adherence
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
Time frame: 6 months
drug adherence
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
Time frame: 12 months
drug adherence
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
Time frame: 24 months
questionnaire of life quality (AFEQT)
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)
Time frame: 1 month
questionnaire of life quality (AFEQT)
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)
Time frame: 6 months
questionnaire of life quality (AFEQT)
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)
Time frame: 12 months
questionnaire of life quality (AFEQT)
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)
Time frame: 24 months
cognitive function (KDSQ)
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.
Time frame: 1 month
cognitive function (KDSQ)
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.
Time frame: 6 months
cognitive function (KDSQ)
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.
Time frame: 12 months
cognitive function (KDSQ)
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.
Time frame: 24 months