NCT04437654

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation Patients With Intermediate Stroke Risk

Interventions

Type	Name	Description
DRUG	Anticoagulation group(Apixaban group)	Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years

Timeline

• Start date: 2020-07-28
• Primary completion: 2026-07-01
• Completion: 2028-10-01
• First posted: 2020-06-18
• Last updated: 2025-02-10

Locations

1 site across 1 country: South Korea