RecruitingPhase 4NCT04437654

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

Enrollment

1,800 participants

Start Date

Jul 28, 2020

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Patients With Intermediate Stroke Risk

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.

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Inclusion Criteria4

Age: 19\~80 years old
CHA2DS2-VASc score 1 for male or 2 for female among nonvalvular atrial fibrillation patients
Patients who agree to register for this study
Patients who can be observed for the progress after treatment

Exclusion Criteria7

Severe liver or kidney dysfunction
Thyroid dysfunction
Pregnant or breastfeeding women
Malignant tumors that have not been completely cured
Severe structural heart disease
Predicted survival is less than 12 months
Patients who do not understand the content of the study or disagree with it

Interventions

DRUGAnticoagulation 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

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NCT04437654