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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)

RECRUITINGPhase 4Sponsored by Yonsei University
Actively Recruiting
PhasePhase 4
SponsorYonsei University
Started2020-07-28
Est. completion2026-07
Eligibility
Age19 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04437654

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

Age: 19 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Atrial Fibrillation Patients With Intermediate Stroke RiskHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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