The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)
NCT ID: NCT04437654
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1800 participants
INTERVENTIONAL
2020-07-28
2028-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anticoagulation group(Apixaban group)
Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
Anticoagulation group(Apixaban group)
Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
Nonanticoagulation group
Standard treatment except anticoagulant for 2 years
No interventions assigned to this group
Interventions
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Anticoagulation group(Apixaban group)
Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Cardiovascular Hospital Yonsei University
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2020-0438
Identifier Type: -
Identifier Source: org_study_id
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