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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Patients with nonvalvular atrial fibrillation receiving apixaban therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of study after six months |
| Monitoring the composite outcome of major, clinically relevant non-major and minor bleeding |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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Eligible patients from participating centers from Bosnia and Herzegovina who are treated on an outpatient basis or in a hospital setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Halima Karakaš | Contact | +387 62 478 535 | HalimaK@Bosnalijek.ba | |
| Una Glamoclija, PhD | Contact | +387 61 147 401 | UnaG@Bosnalijek.ba |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for diseases of the heart, blood vessels and rheumatism | Recruiting | Sarajevo | 71000 | Bosnia and Herzegovina |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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This aim will include any form of bleeding recorded during the study |
| 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 |