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

Who is this study for? Adult patients with atrial fibrillation
What treatments are being studied? Apixaban
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Severance Cardiovascular Hospital Yonsei University
RECRUITING
Seoul
Contact Information
Primary
Boyoung Joung
cby6908@yuhs.ac
82-2-2228-8447
Time Frame
Start Date: 2020-07-28
Estimated Completion Date: 2028-10
Participants
Target number of participants: 1800
Treatments
Experimental: Anticoagulation group(Apixaban group)
Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
No_intervention: Nonanticoagulation group
Standard treatment except anticoagulant for 2 years
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov