The rational behind this observational study is to collect real life data about the use of Trombix® (Rivaroxaban) among patients with atrial fibrillation in Algeria . The aim is to evaluate the safety, efficacy and quality of life.
Trombix® (Rivaroxaban) is used for the treatment of patients with atrial fibrillation. BEKER laboratories are conducting an observation study to evaluate its use among Algerian population in regards to its safety, efficacy and the quality of life of patients after its use.
Study Type
OBSERVATIONAL
Enrollment
398
20mg or 15 mg as per the doctor's prescription
Boumaaza Private healthcare
Algiers, Algeria
CHU Mustapha
Algiers, Algeria
BEDAI private healthcare
Annaba, Algeria
Assessment of reported Serious Adverse Effects linked to Trombix ®
* Assessment of serious adverse effects "major bleeding" linked to Trombix® reported as per the current medical practice for the following: * Incidence of intracranial hemorrhages * Incidence of hemorrhages requiring hospitalization with transfusion * Incidence of fatal hemorrhages * Incidence of critical organ bleeding * Incidence of gastrointestinal bleeding
Time frame: 12 months
Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion
Description the epidemiological characteristics of the patients: demographic data, pathological history, clinical profile at inclusion
Time frame: 12 months
Minor hemorrhages linked to Trombix®
Assessment of the Incidence of minor hemorrhages linked to Trombix® leading to definitive cessation of treatment
Time frame: 12 months
Incidence of any adverse effects
Assessment of the incidence rate of any adverse effects
Time frame: 12 months
Incidence of Trombix® treatment interruptions during 12 months of follow-up
Assessment of the percentage of patients who stopped Trombix® treatment during the 12 months of follow-up
Time frame: 12 months
Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up
Identification of the causes behind stopping treatment with Trombix®
Time frame: 12 months
Incidence of severe thromboses: ischemic stroke / MI / non CNS-Systemic embolism
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Berboucha
Annaba, Algeria
Boudjelal private healthcare
Batna City, Algeria
OKBI Private healthcare
Biskra, Algeria
KHAITER Private healthcare
Blida, Algeria
AOUICHE private healthcare
Constantine, Algeria
HAMDI private healthcare
Constantine, Algeria
Mouffok private healthcare
M'Sila, Algeria
...and 7 more locations
Assessment of the occurrence rate of ischemic stroke and the occurrence rate of systemic embolism during the duration of the study
Time frame: 12 months
Quality of life score
Assessment of the quality of life of patients using a scoring questionnaire adapted to the living conditions of the Algerian population. The scoring varies between the lowest score of 12 and highest of 48. Change in quality of life score during the follow-up period will be evaluated by comparing the mean values.
Time frame: 12 months