Status:
COMPLETED
Observational Study:Safety,Efficacy and Quality of Life of Patients With Atrial Fibrillation, Treated With Trombix®
Lead Sponsor:
Beker Laboratories
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19+ years
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 22 2025
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT06184204
Start Date
December 18 2023
End Date
June 22 2025
Last Update
September 19 2025
Active Locations (17)
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1
Boumaaza Private healthcare
Algiers, Algeria
2
CHU Mustapha
Algiers, Algeria
3
BEDAI private healthcare
Annaba, Algeria
4
Berboucha
Annaba, Algeria