Evaluating anticoagulants for stroke risk in atrial fibrillation patients
The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)
This study is testing if new blood thinners can help people with atrial fibrillation and a moderate risk of stroke stay safe and healthy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04437654 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation who have an intermediate risk of stroke, as determined by their CHA2DS2-VASc score. It aims to assess major safety outcomes such as bleeding events and major efficacy outcomes including strokes and cardiovascular mortality. Additional outcomes will include hospitalization rates, drug compliance, quality of life, cognitive function, and physical strength. The study will involve patients aged 19 to 80 who meet specific inclusion criteria and agree to participate.
Who should consider this trial
Good fit: Ideal candidates are patients aged 19 to 80 with nonvalvular atrial fibrillation and a CHA2DS2-VASc score of 1 for males or 2 for females.
Not a fit: Patients with severe liver or kidney dysfunction, thyroid issues, or those with a predicted survival of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anticoagulation option for patients with atrial fibrillation at intermediate stroke risk.
How similar studies have performed: Other studies have shown promising results with similar approaches using NOACs in atrial fibrillation patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Severance Cardiovascular Hospital Yonsei University — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Boyoung Joung
- Email: cby6908@yuhs.ac
- Phone: 82-2-2228-8447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.