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

NCT06184204 | Completed

• 1 other identifier: TROMBIX.DZ _version 3
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 17

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.

Conditions

Atrial Fibrillation

Keywords

real life; observational; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion

  12 months

• Minor hemorrhages linked to Trombix®

  12 months

• Incidence of any adverse effects

  12 months

• Incidence of Trombix® treatment interruptions during 12 months of follow-up

  12 months

• Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up

  12 months

Study Arms (1)

Patients with confirmed diagnosis of Atrial fibrillation

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

Drug: Trombix® (Rivaroxaban)

Interventions

Trombix® (Rivaroxaban) DRUG

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

Also known as: Trombix®

Patients with confirmed diagnosis of Atrial fibrillation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beker Laboratories: lead

Study Sites (17)

Boumaaza Private healthcare

Algiers, Algeria

Location

CHU Mustapha

Algiers, Algeria

Location

BEDAI private healthcare

Annaba, Algeria

Location

Berboucha

Annaba, Algeria

Location

Boudjelal private healthcare

Batna City, Algeria

Location

OKBI Private healthcare

Biskra, Algeria

Location

KHAITER Private healthcare

Blida, Algeria

Location

AOUICHE private healthcare

Constantine, Algeria

Location

HAMDI private healthcare

Constantine, Algeria

Location

Mouffok private healthcare

M'Sila, Algeria

Location

Ali Lahmar private healthcare

Oran, Algeria

Location

CHU Oran

Oran, Algeria

Location

EID private healthcare

Oran, Algeria

Location

Sebbagh Private Healthcare

Sidi Bel Abbes, Algeria

Location

EPH Tipaza

Tipasa, Algeria

Location

Fernane private healthcare

Tizi Ouzou, Algeria

Location

NASSOUR private healthcare

Tlemcen, Algeria

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pr Aoudia Yazid

  EPH Tipaza

  PRINCIPAL INVESTIGATOR

• Pr ADJEROUD Naima

  Faculty of Medicine of Algiers

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: December 18, 2023
• Primary Completion: March 30, 2025
• Study Completion: June 22, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AL (17)