Observational Study:Safety,Efficacy and Quality of Life of Patients With Atrial Fibrillation, Treated With Trombix®

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Prospective, National, Multicentric, Observational Study to Evaluate the Safety, Efficacy and Quality of Life of Patients With Atrial Fibrillation, Treated With Trombix® (Rivaroxaban).

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Trombix® (Rivaroxaban)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, aged ≥ 19 years. Patient with a diagnosis of atrial fibrillation who requires treatment with Trombix® or switch of Anti-Vitamin K treatment toTrombix® (patient not balanced with current treatment or wishing to change treatment with better manageability). Patient being able to provide free and informed written consent before the study. Exclusion Criteria: Hypersensitivity to the active ingredient or to one of the excipients indicated in the Summary of Product Characteristics of Trombix® Clinically significant progressive bleeding. Injury or illness, if considered to be at significant risk of major bleeding. This may include: current or recent gastrointestinal ulceration, presence of malignant tumors with a high risk of bleeding, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intra-spinal or intracerebral vascular anomalies. Concomitant treatment with any other anticoagulant, for example, unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran exilate, apixaban, etc.) except in specific circumstances of switching from anticoagulant treatment or in the case of administration of UFH at doses necessary to maintain the permeability of a central venous or arterial catheter. Liver injury associated with coagulopathy and clinically significant bleeding risk, including cirrhotic patients with Child Pugh score class B or C. Pregnancy and breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with confirmed diagnosis of Atrial fibrillation<br>male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation | Drug: Trombix® (Rivaroxaban)<br>* 20mg or 15 mg as per the doctor's prescription<br>* Other names: Trombix®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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® | 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
real life, observational, safety, efficacy