NCT07458191Recruiting
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)
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 9 Oct 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Bosnalijek D.D
- Diseases
- Atrial fibrillation
- NCT number
- NCT07458191
What you commit to
- Study type: Observational
- Planned participants: 800
- From 9 Oct 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who previously used apixaban in therapy.
- Withdrawal Criteria:
- Deterioration of the clinical picture of the underlying disease that requires discontinuation of investigational therapy.
- Development of serious adverse events that require discontinuation of therapy.
Other illness
- Positive history of angioneurotic edema.
- Active, clinically significant bleeding.
- Congenital or acquired bleeding disorder.
- The presence of a malignant tumor.
- Current or recent presence of gastrointestinal ulcer.
- Positive history of arteriovenous malformations, vascular aneurysms or intraspinal and intracerebral vascular anomalies.
- Patients with artificial heart valves.
- Liver cirrhosis and active liver disease associated with coagulopathy and clinically significant risk of bleeding.
- Development of another disease that affects the course of research.
Lab values
- Dialysis patients (GFR \<15 ml/min).
Other
- The presence of established or suspected esophageal varices.
- Simultaneous use of other anticoagulants.
- Pregnancy and breastfeeding.
- Occurrence of pregnancy.
Who the study is looking for
- Patients over 18 years of age.
- Hemodynamically stable patients.
- Patients with non-valvular atrial fibrillation.
- Patients in whom the investigator, based on clinical assessment makes a decision to introduce apixaban therapy.
- Patients who are on apixaban therapy for the first time
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinic for diseases of the heart, blood vessels and rheumatism Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.