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

NCT ID: NCT06184204

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-18

Study Completion Date

2025-06-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with confirmed diagnosis of Atrial fibrillation

male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation

Trombix® (Rivaroxaban)

Intervention Type DRUG

20mg or 15 mg as per the doctor's prescription

Interventions

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Trombix® (Rivaroxaban)

20mg or 15 mg as per the doctor's prescription

Intervention Type DRUG

Other Intervention Names

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Trombix®

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beker Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pr Aoudia Yazid

Role: PRINCIPAL_INVESTIGATOR

EPH Tipaza

Pr ADJEROUD Naima

Role: STUDY_CHAIR

Faculty of Medicine of Algiers

Locations

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Boumaaza Private healthcare

Algiers, , Algeria

Site Status

CHU Mustapha

Algiers, , Algeria

Site Status

BEDAI private healthcare

Annaba, , Algeria

Site Status

Berboucha

Annaba, , Algeria

Site Status

Boudjelal private healthcare

Batna City, , Algeria

Site Status

OKBI Private healthcare

Biskra, , Algeria

Site Status

KHAITER Private healthcare

Blida, , Algeria

Site Status

AOUICHE private healthcare

Constantine, , Algeria

Site Status

HAMDI private healthcare

Constantine, , Algeria

Site Status

Mouffok private healthcare

M'Sila, , Algeria

Site Status

Ali Lahmar private healthcare

Oran, , Algeria

Site Status

CHU Oran

Oran, , Algeria

Site Status

EID private healthcare

Oran, , Algeria

Site Status

Sebbagh Private Healthcare

Sidi Bel Abbes, , Algeria

Site Status

EPH Tipaza

Tipasa, , Algeria

Site Status

Fernane private healthcare

Tizi Ouzou, , Algeria

Site Status

NASSOUR private healthcare

Tlemcen, , Algeria

Site Status

Countries

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Algeria

Other Identifiers

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TROMBIX.DZ _version 3

Identifier Type: -

Identifier Source: org_study_id

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