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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elxaban group<br>AF patients taking Elxaban | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major bleeding | 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 | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elxaban