RecruitingNCT07458191

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)

Sponsor

Bosnalijek D.D

Enrollment

800 participants

Start Date

Oct 9, 2025

Study Type

OBSERVATIONAL

Conditions

Nonvalvular Atrial Fibrillation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study observes how safely patients with atrial fibrillation (an irregular heartbeat) take apixaban—a blood thinner used to reduce stroke risk—and how well they stick to their prescribed dose over time. Atrial fibrillation increases stroke risk, and blood thinners must be taken consistently to be effective. **You may be eligible if...** - You are over 18 years old - You have atrial fibrillation (not caused by a heart valve problem) - Your doctor has decided to start you on apixaban for the first time - You are medically stable **You may NOT be eligible if...** - You have a history of severe allergic swelling (angioedema) - You have active bleeding or a bleeding disorder - You have an active cancer or gastrointestinal ulcer - You have artificial heart valves - You have severe liver disease with bleeding risk - You have kidney failure requiring dialysis - You are taking other blood thinners simultaneously - You are pregnant or breastfeeding - You have previously taken apixaban Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApixaban

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).

Locations(1)

Clinic for diseases of the heart, blood vessels and rheumatism

Sarajevo, Bosnia and Herzegovina

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NCT07458191

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