Apixaban safety and adherence in nonvalvular atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational follow-up of adults with nonvalvular atrial fibrillation who are starting apixaban for the first time to record safety and adherence outcomes. Participants are followed for six months with four scheduled measurements, with the first and last visits in person and the middle two visits possible by telephone if clinically appropriate. The study captures incidence of major bleeding, clinically relevant non-major bleeding, and other adverse reactions unrelated to bleeding. Enrollment excludes patients with conditions that substantially increase bleeding risk or contraindicate apixaban, such as active bleeding, severe liver disease, dialysis, mechanical valves, or pregnancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinic for diseases of the heart, blood vessels and rheumatism
  Sarajevo, Bosnia and Herzegovina Recruiting

Study contacts

• Study coordinator: Halima Karakaš
• Email: HalimaK@Bosnalijek.ba
• Phone: +387 62 478 535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.