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The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)
Sponsor: Yonsei University
Summary
The purpose of this study is to investigate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOAC) in atrial fibrillation patients with intermediate stroke risk (CHA2DS2-VASc score 1 for male, 2 for female). A. Major safety results include major bleeding and clinically relevant non-major bleeding. B. Major efficacy results include strokes, systemic embolism and cardiovascular mortality. C. Other results include myocardial infarction, pulmonary embolism, transient ischemic attack, hospitalization, drug compliance, quality of life questionnaire (AFEQT), cognitive function (KDSQ), aging questionnaire(K-Frail) and hand grip strength.
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1800
Start Date
2020-07-28
Completion Date
2028-10
Last Updated
2025-02-10
Healthy Volunteers
No
Interventions
Anticoagulation group(Apixaban group)
Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
Locations (1)
Severance Cardiovascular Hospital Yonsei University
Seoul, South Korea