Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation (NCT07458191) | Clinical Trial Compass
RecruitingNot Applicable
Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation
Bosnia and Herzegovina800 participantsStarted 2025-10-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite primary outcome including incidence of major bleeding and clinically relevant non-major bleeding
Timeframe: From enrollment to the end of study after six months