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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04125641
• Other study ID #: 4-2019-0536
• Status: Recruiting
• Start date: January 2, 2020
• Est. completion date: March 2024

Study information

• Verified date: January 2020
• Source: Yonsei University
• Contact: Boyoung Jung
• Phone: +82 02-2228-8447
• Email: cby6908[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 2024
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Stroke	Stroke included both ischemic and hemorrhagic stroke.	1 month
Primary	Stroke	Stroke included both ischemic and hemorrhagic stroke.	6 months
Primary	Stroke	Stroke included both ischemic and hemorrhagic stroke.	12 months
Primary	Stroke	Stroke included both ischemic and hemorrhagic stroke.	24 months
Primary	systemic embolism	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	1 month
Primary	systemic embolism	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	6 months
Primary	systemic embolism	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	12 months
Primary	systemic embolism	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	24 months
Primary	death	Death included overall death, cardiovascular death and non-cardiovascular death.	1 month
Primary	death	Death included overall death, cardiovascular death and non-cardiovascular death.	6 months
Primary	death	Death included overall death, cardiovascular death and non-cardiovascular death.	12 months
Primary	death	Death included overall death, cardiovascular death and non-cardiovascular death.	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	drug adherence	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	1 month
Secondary	drug adherence	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	6 months
Secondary	drug adherence	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	12 months
Secondary	drug adherence	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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