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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elxaban group | AF patients taking Elxaban |
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| Measure | Description | Time Frame |
|---|---|---|
| major bleeding | Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).
| 1 month |
| major bleeding | Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).
| 6 months |
| major bleeding | Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).
| 12 months |
| major bleeding | Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Atrial fibrillatin patients taking Elxaban in general hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boyoung Jung | Contact | +82 02-2228-8447 | cby6908@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 24 months |
| Stroke | Stroke included both ischemic and hemorrhagic stroke. | 1 month |
| Stroke | Stroke included both ischemic and hemorrhagic stroke. | 6 months |
| Stroke | Stroke included both ischemic and hemorrhagic stroke. | 12 months |
| Stroke | Stroke included both ischemic and hemorrhagic stroke. | 24 months |
| systemic embolism | An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion | 1 month |
| systemic embolism | An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion | 6 months |
| systemic embolism | An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion | 12 months |
| systemic embolism | An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion | 24 months |
| death | Death included overall death, cardiovascular death and non-cardiovascular death. | 1 month |
| death | Death included overall death, cardiovascular death and non-cardiovascular death. | 6 months |
| death | Death included overall death, cardiovascular death and non-cardiovascular death. | 12 months |
| death | Death included overall death, cardiovascular death and non-cardiovascular death. | 24 months |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 months |
| drug adherence | Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed | 1 month |
| drug adherence | Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed | 6 months |
| drug adherence | Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed | 12 months |
| drug adherence | 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) | 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
| 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
| 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
| 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
| 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. | 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. | 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. | 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. | 24 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |