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

  • STATUS
    Recruiting
  • End date
    Oct 25, 2028
  • participants needed
    1800
  • sponsor
    Yonsei University
Updated on 25 January 2021

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).

  1. Major safety results include major bleeding and clinically relevant non-major bleeding.
  2. 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.

Details
Condition Atrial Fibrillation Patients With Intermediate Stroke Risk
Treatment Anticoagulation group(Apixaban group)
Clinical Study IdentifierNCT04437654
SponsorYonsei University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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