NCT07458191

Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation

Monitoring Safety and Therapeutic Adherence During Anticoagulant Prophylaxis With Apixa® in Patients With Nonvalvular Atrial Fibrillation (Praćenje Sigurnosti i Terapijske Adherence u Toku Antikoagulantne Profilakse Lijekom Apixa® Kod Pacijenata sa Nevalvularnom Atrijalnom Fibrilacijom)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Bosnalijek D.D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Nonvalvular Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Apixaban	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).

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-03-09
• Last updated: 2026-03-11

Locations

1 site across 1 country: Bosnia and Herzegovina