Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07458191

Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for diseases of the heart, blood vessels and rheumatism

Sarajevo, 71000, Bosnia and Herzegovina

Location status: Recruiting

Location contact

Alden Begić, PhD

CONTACT

[email protected]

+387 33 297 500

Alden Begić, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apixaban

Drug

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).

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Monitoring of adherence to anticoagulant prophylaxis

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

    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.

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Halima Karakaš

CONTACT

[email protected]

+387 62 478 535

Una Glamoclija, PhD

CONTACT

[email protected]

+387 61 147 401

Sponsors and collaborators

Lead sponsor

Bosnalijek D.D

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.