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

Plain Language Summary

Simplified for easier understanding

This trial studies whether blood-thinning medications (NOACs) reduce stroke risk in people with atrial fibrillation who have an intermediate stroke risk score. **You may be eligible if...** - You are 19–80 years old - You have non-valvular atrial fibrillation with a CHA2DS2-VASc score of 1 (men) or 2 (women) - You agree to participate and can be followed over time **You may NOT be eligible if...** - You have severe liver or kidney problems - You have thyroid disease - You are pregnant or breastfeeding - You have an untreated malignant tumor - You have severe structural heart disease - Your expected survival is less than 12 months - You do not understand or disagree with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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