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

Beker Laboratories

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Trombix® (Rivaroxaban)

Study type

Observational

Funder types

Industry

Identifiers

NCT06184204

TROMBIX.DZ _version 3

Details and patient eligibility

About

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.

Full 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.

Enrollment

398 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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