The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)

• Status: Recruiting
• Trial end date: 2028-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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