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
- Are there results?
- Not yet: the study is under way
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.
Show all 18Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07458191
- Acronym / sponsor ID
- APX-01-2025
- Conditions
- Nonvalvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Bosnalijek D.DIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apixaban | – | Drug: ApixabanPatients with nonvalvular atrial fibrillation receiving apixaban therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanPatients 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). | Drug | Apixaban |
Primary outcome
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.
3 secondary outcomes
Monitoring of adherence to anticoagulant prophylaxis
Time frame: From enrollment to the end of study after six months
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
Monitoring the frequency and type of other adverse reactions, excluding bleeding
Time frame: From enrollment to the end of study after six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonvalvular Atrial Fibrillation, run by Bosnalijek D.D at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Halima Karakaš (+387 62 478 535, HalimaK@Bosnalijek.ba), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.