Actively Recruiting
Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation
Led by Bosnalijek D.D · Updated on 2026-03-11
800
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age.
- Hemodynamically stable patients.
- Patients with non-valvular atrial fibrillation.
- Patients for whom the investigator decides to start apixaban therapy.
- Patients starting apixaban therapy for the first time.
You will not qualify if you...
- History of angioneurotic edema.
- Active, clinically significant bleeding.
- Congenital or acquired bleeding disorders.
- Presence of a malignant tumor.
- Current or recent gastrointestinal ulcer.
- Established or suspected esophageal varices.
- History of arteriovenous malformations, vascular aneurysms, or intraspinal/intracerebral vascular anomalies.
- Patients with artificial heart valves.
- Liver cirrhosis or active liver disease with coagulopathy and significant bleeding risk.
- Dialysis patients with GFR less than 15 ml/min.
- Simultaneous use of other anticoagulants.
- Pregnancy or breastfeeding.
- Previous use of apixaban in therapy.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinic for diseases of the heart, blood vessels and rheumatism
Sarajevo, Bosnia and Herzegovina, 71000
Actively Recruiting
Research Team
H
Halima Karakaš
CONTACT
U
Una Glamoclija, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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