An observational study in Atrial Fibrillation, sponsored by Beker Laboratories. Completed at 17 sites in Algeria. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Beker Laboratories · Observational
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 398 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Beker Laboratories is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The subjects in the study were enrolled from different centers (public and private sectors) across different regions in the country; East, Center and West of Algeria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation
Drug: Trombix® (Rivaroxaban)
20mg or 15 mg as per the doctor's prescription
Also known as: Trombix®
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Beker Laboratories