Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation

NCT07458191 | Recruiting

• 1 other identifier: APX-01-2025
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonvalvular Atrial Fibrillation

Outcome Measures

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.

  From enrollment to the end of study after six months

Secondary Outcomes (3)

• Monitoring of adherence to anticoagulant prophylaxis

  From enrollment to the end of study after six months

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

  From enrollment to the end of study after six months

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

  From enrollment to the end of study after six months

Study Arms (1)

Apixaban

Patients with nonvalvular atrial fibrillation receiving apixaban therapy

Drug: Apixaban

Interventions

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).

Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bosnalijek D.D: lead

Study Sites (1)

Clinic for diseases of the heart, blood vessels and rheumatism

Sarajevo, 71000, Bosnia and Herzegovina

RECRUITING

MeSH Terms

Interventions

apixaban

Central Study Contacts

Halima Karakaš

CONTACT

+387 62 478 535; HalimaK@Bosnalijek.ba

Una Glamoclija, PhD

CONTACT

+387 61 147 401; UnaG@Bosnalijek.ba

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: October 9, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

BO (1)