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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with confirmed diagnosis of Atrial fibrillation | male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trombix® (Rivaroxaban) | Drug | 20mg or 15 mg as per the doctor's prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of reported Serious Adverse Effects linked to Trombix ® |
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Minor hemorrhages linked to Trombix® |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pr Aoudia Yazid | EPH Tipaza | Principal Investigator |
| Pr ADJEROUD Naima | Faculty of Medicine of Algiers | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boumaaza Private healthcare | Algiers | Algeria | ||||
| CHU Mustapha |
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Assessment of the Incidence of minor hemorrhages linked to Trombix® leading to definitive cessation of treatment |
| 12 months |
| Incidence of any adverse effects | Assessment of the incidence rate of any adverse effects | 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 | 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® | 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 | 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. | 12 months |
| Algiers |
| Algeria |
| BEDAI private healthcare | Annaba | Algeria |
| 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 |
| Ali Lahmar private healthcare | Oran | Algeria |
| CHU Oran | Oran | Algeria |
| EID private healthcare | Oran | Algeria |
| Sebbagh Private Healthcare | Sidi Bel Abbes | Algeria |
| EPH Tipaza | Tipasa | Algeria |
| Fernane private healthcare | Tizi Ouzou | Algeria |
| NASSOUR private healthcare | Tlemcen | Algeria |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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