Apixaban safety and adherence in nonvalvular 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)

See if apixaban is safe and how well adults with nonvalvular atrial fibrillation stick to the medication over six months.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bosnalijek D.D (Industry-sponsored)
• Locations: 1 site (Sarajevo)
• Trial ID: NCT07458191 on ClinicalTrials.gov

What this trial studies

This is an observational follow-up of adults with nonvalvular atrial fibrillation who are starting apixaban for the first time to record safety and adherence outcomes. Participants are followed for six months with four scheduled measurements, with the first and last visits in person and the middle two visits possible by telephone if clinically appropriate. The study captures incidence of major bleeding, clinically relevant non-major bleeding, and other adverse reactions unrelated to bleeding. Enrollment excludes patients with conditions that substantially increase bleeding risk or contraindicate apixaban, such as active bleeding, severe liver disease, dialysis, mechanical valves, or pregnancy.

Who should consider this trial

Good fit: Adults with nonvalvular atrial fibrillation who are hemodynamically stable and starting apixaban for the first time, and who do not meet exclusion criteria such as active bleeding, significant liver disease, dialysis, or pregnancy.

Not a fit: Patients with mechanical heart valves, active or high-risk bleeding conditions, severe liver disease, on dialysis (GFR <15 ml/min), current cancer, or who are pregnant are excluded and are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the study could clarify real-world bleeding risks and adherence patterns with apixaban and help clinicians tailor anticoagulation to reduce strokes and bleeding.

How similar studies have performed: Large randomized trials (e.g., ARISTOTLE) and multiple registries have shown apixaban reduces stroke risk and has favorable bleeding profiles compared with warfarin, and prior observational work has described adherence and bleeding rates, so this study builds on established evidence.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* The presence of established or suspected esophageal varices.
* 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.
* Dialysis patients (GFR \<15 ml/min).
* Simultaneous use of other anticoagulants.
* Pregnancy and breastfeeding.
* 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.
* Occurrence of pregnancy.
* Development of another disease that affects the course of research.

Where this trial is running

Sarajevo

• Clinic for diseases of the heart, blood vessels and rheumatism — Sarajevo, Bosnia and Herzegovina (Recruiting)

Study contacts

• Study coordinator: Halima Karakaš

Conditions Nonvalvular Atrial Fibrillation