Monitoring Safety and Therapeutic Adherence During Anticoagulant Prophylaxis With Apixaban in Patients With Nonvalvular Atrial Fibrillation

What this Trial Is About

This observational study focuses on patients with nonvalvular atrial fibrillation who are receiving anticoagulant prophylaxis with apixaban. The research aims to evaluate the safety of apixaban by tracking the incidence of major bleeding and clinically relevant non-major bleeding, therapy adherence, and other adverse reactions excluding bleeding. The study is sponsored by Bosnalijek D.D and follows participants over six months to gather comprehensive safety and adherence data. Participants will take apixaban orally, with a standard dose of 5 mg twice daily or a reduced dose of 2.5 mg twice daily for those aged 80 or older, weighing 60 kg or less, or with specific serum creatinine levels. The study involves four measurements over six months; the first and last are in-person, while the middle two can be done by telephone if needed. Immediate reporting of any bleeding or serious adverse reactions is required through unscheduled visits. During the six-month follow-up, researchers will collect data on bleeding events, adverse reactions, and medication adherence using the BARS scale. Participants will undergo scheduled assessments at four time points, and any serious side effects will be promptly recorded. The primary outcome is the combined incidence of major and clinically relevant non-major bleeding. Secondary outcomes include adherence rates, overall bleeding events, and other adverse reactions during this period.

Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation