Assessing stroke risk in patients with newly diagnosed atrial fibrillation
Individualized Stroke Risk Scores and Hemostatic Profile in Oral Anticoagulant-naïve (OAC-naïve) Patients With Non-valvular Atrial Fibrillation (NVAF)
This study is testing how to identify stroke risk in people who have just been diagnosed with atrial fibrillation to see who might need blood-thinning medication to prevent strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Esbjerg, Region Syddanmark) |
| Trial ID | NCT06949319 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have been newly diagnosed with non-valvular atrial fibrillation (NVAF) and have not yet received oral anticoagulation therapy. It aims to evaluate stroke risk using established risk assessment tools like the CHA2DS2-VASc score and the ABC-stroke score, which incorporate clinical factors and biomarkers. By stratifying patients based on their risk, the study seeks to identify those who would benefit most from anticoagulation therapy to prevent strokes. The study will involve collecting data from patients at Esbjerg Hospital in Denmark.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed non-valvular atrial fibrillation who have not received any oral anticoagulation therapy.
Not a fit: Patients currently undergoing oral anticoagulation treatment or those with valvular atrial fibrillation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective stroke prevention strategies for patients with atrial fibrillation.
How similar studies have performed: Previous studies have shown success in using risk assessment tools for stroke prevention in atrial fibrillation, making this approach both relevant and tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with newly diagnosed non-valvular atrial fibrillation (NVAF), who are oral anticoagulant-naïve (OAC-naïve) prior to inclusion. * Age ≥ 18 years. * Signed informed consent. Exclusion Criteria: * Ongoing OAC treatment prior to inclusion. * Valvular AF (mechanical heart valves or moderate-severe mitral stenosis). * Secondary AF due to an acute reversible precipitant (e.g., infection, surgery, thyrotoxicosis, etc.). * Pregnant or breastfeeding women. * Treatment with oral contraceptives. * End-stage renal disease (creatinine clearance \<15 mL/min as calculated by the Cockcroft-Gault equation). * Connective tissue diseases. * Active cancer (cancer diagnosis not followed by curative procedures six months from the date of diagnosis). * Major surgery (\< three months). * Acute coronary syndrome, stroke/TIA, and venous thromboembolism within three months prior to inclusion. * Thrombophilia. * Significant liver disease. * Significant hematological disease.
Where this trial is running
Esbjerg, Region Syddanmark
- Esbjerg Hospital - University Hospital of Southern Denmark, involving collaboration between the Unit for Thrombosis Research, Department of Clinical Diagnostics and the Department of Cardiology. — Esbjerg, Region Syddanmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Nedim Tojaga, Medical degree & PhD-student.
- Email: nedim.tojaga@rsyd.dk
- Phone: +4552752212
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.