Actively Recruiting
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
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOAC) in people with atrial fibrillation who have an intermediate risk of stroke, defined by a CHA2DS2-VASc score of 1 for males and 2 for females. This study aims to understand how well these medications work in preventing strokes and other related cardiovascular events, as well as their safety regarding bleeding risks. The study also looks at other health aspects like heart attacks, hospitalizations, cognitive function, and quality of life. Participants are randomly assigned to one of two groups: one group receives Apixaban, a NOAC, taken as 5mg twice daily or 2.5mg twice daily if dose reduction criteria are met, for a period of 2 years. The other group receives standard treatment that does not include anticoagulants for the same duration. There is no masking or blinding, and the treatments are directly compared over the two-year period. During the study, participants will be monitored regularly at baseline, 1, 6, 12, 18, and 24 months for a composite of outcomes including stroke, systemic embolism, cardiovascular death, major bleeding, and other related events. Researchers will also assess drug adherence, quality of life through questionnaires, cognitive function, aging indicators, and hand grip strength. The study involves ongoing observation and data collection to evaluate both the benefits and risks of the treatment over two years.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Age between 19 and 80 years old
- Nonvalvular atrial fibrillation with CHA2DS2-VASc score of 1 for males or 2 for females
- Agree to participate in the study
- Able to be observed for treatment progress
You will not qualify if you...
- Severe liver or kidney dysfunction
- Thyroid dysfunction
- Pregnant or breastfeeding women
- Uncured malignant tumors
- Severe structural heart disease
- Predicted survival less than 12 months
- Unable to understand or disagree with the study content
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 years
Participants receive anticoagulant treatment with Apixaban or standard treatment without anticoagulants for 2 years.
Regular visits throughout treatment period
Trial Site Locations
Total: 1 location
1
Severance Cardiovascular Hospital Yonsei University
Seoul, South Korea
Actively Recruiting
Research Team
B
Boyoung Joung
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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