Nonvalvular Atrial FibrillationNCT07458191
Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation
An observational study of Nonvalvular Atrial Fibrillation, run by Bosnalijek D.D at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonvalvular Atrial Fibrillation
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 9 Oct 2025to Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients from participating centers from Bosnia and Herzegovina who are treated on an outpatient basis or in a hospital setting.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
Clinic for diseases of the heart, blood vessels and rheumatism
Sarajevo, 71000
Alden Begić, PhD, +387 33 297 500, alden.begic@kcus.ba
Alden Begić, PhD
About this study
Official 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)
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
- Being tested
- Apixaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Patients with nonvalvular atrial fibrillation receiving apixaban therapy Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of study after six months
Secondary outcomes (3)
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.
Measured: From enrollment to the end of study after six months
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
Measured: From enrollment to the end of study after six months
Monitoring the frequency and type of other adverse reactions, excluding bleeding
Measured: From enrollment to the end of study after six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start9 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvalvular Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bosnalijek D.D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458191
- Sponsor's protocol ID
- APX-01-2025
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No