Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation
ConditionNonvalvular Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBosnalijek D.D
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Positive history of angioneurotic edema.
Active, clinically significant bleeding.
Congenital or acquired bleeding disorder.
The presence of a malignant tumor.
Trial population
Eligible patients from participating centers from Bosnia and Herzegovina who are treated on an outpatient basis or in a hospital setting.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Apixaban
DrugPatients 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).
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Apixaban1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of study after six monthsSecondary outcomes
1
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.
Time frame
From enrollment to the end of study after six months2
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
Time frame
From enrollment to the end of study after six months3
Monitoring the frequency and type of other adverse reactions, excluding bleeding
Time frame
From enrollment to the end of study after six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov