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RECRUITING
NCT04437654
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

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