Stroke Risk Assessment and Markers of Blood Clotting in Patients With Newly Diagnosed Non-valvular Atrial Fibrillation (NVAF), Who Have Not Received Oral Anticoagulation Therapy (OAC-therapy) Prior to Inclusion

Launched by NEDIM TOJAGA · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how to better assess the risk of stroke in patients who have just been diagnosed with a heart condition called non-valvular atrial fibrillation (AF). AF is a common heart rhythm disorder that can lead to serious complications like stroke. The study aims to improve the current methods used to evaluate stroke risk by including additional factors, such as the size and function of the heart's upper chambers and certain blood markers that indicate how likely someone is to form blood clots. By doing this, the researchers hope to identify patients who may benefit from blood-thinning medications while avoiding unnecessary treatment for those who don't need it.

To participate in this trial, individuals must be at least 18 years old, newly diagnosed with non-valvular atrial fibrillation, and not currently taking blood thinners. Participants will receive a blood test, an ultrasound of their heart, and will be monitored for their heart rhythm for a week. The study is being conducted at Esbjerg Hospital in Denmark, and participants will be recruited with the help of their general practitioners. This research is important because it could lead to better, more personalized treatment options for people with AF, ultimately helping to reduce their risk of stroke.

Gender

ALL

Eligibility 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.