Assessing stroke risk in patients with newly diagnosed atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.