Actively Recruiting

Phase 4
Age: 19Years - 80Years
All Genders
NCT04437654

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

Led by Yonsei University · Updated on 2025-02-10

1800

Participants Needed

1

Research Sites

426 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 to 80 years old
  • CHA2DS2-VASc score of 1 for males or 2 for females among patients with nonvalvular atrial fibrillation
  • Patients willing to register for this study
  • Patients who can be followed for progress after treatment
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Severance Cardiovascular Hospital Yonsei University

Seoul, South Korea

Actively Recruiting

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Research Team

B

Boyoung Joung

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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