The aim of this observational study is to evaluate safety and therapeutic adherence during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation. The main questions it aims to answer are: * What is the incidence of major bleeding and clinically relevant non-major bleeding during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation? * What is therapy adherence during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation? * What is frequency and types of other adverse reactions, excluding bleeding, during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation? Participants will be followed for six months through four measurements. The first and fourth measurements will be performed in person, while the remaining measurements can also be recorded by telephone, if the patient's condition allows. Any bleeding or serious adverse reactions to the medication being administered will be recorded immediately, through unscheduled measurements. Adverse reactions will be recorded at each measurement. Adherence to the medication being administered will be evaluated using the BARS scale.
Study Type
OBSERVATIONAL
Enrollment
800
Patients will receive orally 5 mg of apixaban twice daily or reduced dose 2.5 mg, twice a day orally, in patients with at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg or serum creatinine ≥ 1.5 mg/dl (133 μmol/l).
Clinic for diseases of the heart, blood vessels and rheumatism
Sarajevo, Bosnia and Herzegovina
RECRUITINGComposite primary outcome including incidence of major bleeding and clinically relevant non-major bleeding
The primary outcome will be bleeding, composed of major bleeding reported according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and non-major bleeding including prolonged bleeding from cuts on the skin, bleeding from gums or nose, blood in the stool and/or urine, vomiting and/or coughing up blood, and prolonged or heavier menstruation.
Time frame: From enrollment to the end of study after six months
Monitoring of adherence to anticoagulant prophylaxis
Adherence to the administered medication will be evaluated using the Brief Adherence Rating Scale (BARS). The final scale has range from 0 to 100, higher values meaning better adherence.
Time frame: From enrollment to the end of study after six months
Monitoring the composite outcome of major, clinically relevant non-major and minor bleeding
This aim will include any form of bleeding recorded during the study
Time frame: From enrollment to the end of study after six months
Monitoring the frequency and type of other adverse reactions, excluding bleeding
Time frame: From enrollment to the end of study after six months
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