Clinical trial NCT04125641: Non-Interventional Study on Effectiveness of Elxaban Tab. in Patients With Non-valvular Atrial Fibrillation
Official title: Non-Interventional Study on Effectiveness of Elxaban Tab. in Patients With Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Elxaban
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial fibrillatin patients taking Elxaban in general hospital

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: major bleeding
timeFrame: 1 month
measure: major bleeding
timeFrame: 6 months
measure: major bleeding
timeFrame: 12 months
measure: major bleeding
timeFrame: 24 months
measure: Stroke
timeFrame: 1 month
measure: Stroke
timeFrame: 6 months
measure: Stroke
timeFrame: 12 months
measure: Stroke
timeFrame: 24 months
measure: systemic embolism
timeFrame: 1 month
measure: systemic embolism
timeFrame: 6 months
measure: systemic embolism
timeFrame: 12 months
measure: systemic embolism
timeFrame: 24 months
measure: death
timeFrame: 1 month
measure: death
timeFrame: 6 months
measure: death
timeFrame: 12 months
measure: death
timeFrame: 24 months
Secondary outcomes:
measure: other clinical events: acute myocardial infarction
timeFrame: 1 month
measure: other clinical events: acute myocardial infarction
timeFrame: 6 months
measure: other clinical events: acute myocardial infarction
timeFrame: 12 months
measure: other clinical events: acute myocardial infarction
timeFrame: 24 months
measure: other clinical events: pulmonary embolism
timeFrame: 1 month
measure: other clinical events: pulmonary embolism
timeFrame: 6 months
measure: other clinical events: pulmonary embolism
timeFrame: 12 months
measure: other clinical events: pulmonary embolism
timeFrame: 24 months
measure: other clinical events: transient ischemic attack
timeFrame: 1 month
measure: other clinical events: transient ischemic attack
timeFrame: 6 months
measure: other clinical events: transient ischemic attack
timeFrame: 12 months
measure: other clinical events: transient ischemic attack
timeFrame: 24 months
measure: drug adherence
timeFrame: 1 month
measure: drug adherence
timeFrame: 6 months
measure: drug adherence
timeFrame: 12 months
measure: drug adherence
timeFrame: 24 months
measure: questionnaire of life quality (AFEQT)
timeFrame: 1 month
measure: questionnaire of life quality (AFEQT)
timeFrame: 6 months
measure: questionnaire of life quality (AFEQT)
timeFrame: 12 months
measure: questionnaire of life quality (AFEQT)
timeFrame: 24 months
measure: cognitive function (KDSQ)
timeFrame: 1 month
measure: cognitive function (KDSQ)
timeFrame: 6 months
measure: cognitive function (KDSQ)
timeFrame: 12 months
measure: cognitive function (KDSQ)
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References: