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RecruitingNCT07458191Updated Mar 11, 2026

Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation

An observational study in Nonvalvular Atrial Fibrillation, sponsored by Bosnalijek D.D. Recruiting at 1 site in Bosnia and Herzegovina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Bosnalijek D.D · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Nonvalvular Atrial Fibrillation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Eligible patients from participating centers from Bosnia and Herzegovina who are treated on an outpatient basis or in a hospital setting.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • Apixaban

    Patients with nonvalvular atrial fibrillation receiving apixaban therapy

    Drug: Apixaban

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).

05

What researchers measure

Primary outcomes

  1. Composite primary outcome including incidence of major bleeding and clinically relevant non-major bleeding

    The primary outcome will be bleeding, composed of major bleeding reported according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and non-major bleeding including prolonged bleeding from cuts on the skin, bleeding from gums or nose, blood in the stool and/or urine, vomiting and/or coughing up blood, and prolonged or heavier menstruation.

    Time frame: From enrollment to the end of study after six months

Secondary outcomes

  1. Monitoring of adherence to anticoagulant prophylaxis

    Adherence to the administered medication will be evaluated using the Brief Adherence Rating Scale (BARS). The final scale has range from 0 to 100, higher values meaning better adherence.

    Time frame: From enrollment to the end of study after six months

  2. Monitoring the composite outcome of major, clinically relevant non-major and minor bleeding

    This aim will include any form of bleeding recorded during the study

    Time frame: From enrollment to the end of study after six months

  3. Monitoring the frequency and type of other adverse reactions, excluding bleeding

    Time frame: From enrollment to the end of study after six months

06

Study locations

1 of 1 sites recruiting
  • Clinic for diseases of the heart, blood vessels and rheumatism
    Sarajevo, 71000, Bosnia and Herzegovina
    • Alden Begić, PhD · Contact · alden.begic@kcus.ba · +387 33 297 500
    • Alden Begić, PhD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT07458191
Lead sponsor
Bosnalijek D.D
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Oct 9, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Mar 11, 2026

Study contacts

Halima Karakaš
Contact
HalimaK@Bosnalijek.ba
+387 62 478 535
Una Glamoclija, PhD
Contact
UnaG@Bosnalijek.ba
+387 61 147 401

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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