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

September 16, 2025 updated by: Beker Laboratories

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Algeria
      • Algiers, Algeria
        • Boumaaza Private healthcare
      • Algiers, Algeria
        • CHU Mustapha
      • Annaba, Algeria
        • BEDAI private healthcare
      • Annaba, Algeria
        • Berboucha
      • Batna City, Algeria
        • Boudjelal private healthcare
      • Biskra, Algeria
        • OKBI Private healthcare
      • Blida, Algeria
        • KHAITER Private healthcare
      • Constantine, Algeria
        • AOUICHE private healthcare
      • Constantine, Algeria
        • HAMDI private healthcare
      • M'Sila, Algeria
        • Mouffok private healthcare
      • Oran, Algeria
        • Ali Lahmar private healthcare
      • Oran, Algeria
        • CHU Oran
      • Oran, Algeria
        • EID private healthcare
      • Sidi Bel Abbes, Algeria
        • Sebbagh Private Healthcare
      • Tipasa, Algeria
        • EPH Tipaza
      • Tizi Ouzou, Algeria
        • Fernane private healthcare
      • Tlemcen, Algeria
        • NASSOUR private healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with confirmed diagnosis of Atrial fibrillation
male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation
Drug: Trombix® (Rivaroxaban)
20mg or 15 mg as per the doctor's prescription
Other Names:
  • Trombix®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of reported Serious Adverse Effects linked to Trombix ®
Time Frame: 12 months
  • 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion
Time Frame: 12 months
Description the epidemiological characteristics of the patients: demographic data, pathological history, clinical profile at inclusion
12 months
Minor hemorrhages linked to Trombix®
Time Frame: 12 months
Assessment of the Incidence of minor hemorrhages linked to Trombix® leading to definitive cessation of treatment
12 months
Incidence of any adverse effects
Time Frame: 12 months
Assessment of the incidence rate of any adverse effects
12 months
Incidence of Trombix® treatment interruptions during 12 months of follow-up
Time Frame: 12 months
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
Time Frame: 12 months
Identification of the causes behind stopping treatment with Trombix®
12 months
Incidence of severe thromboses: ischemic stroke / MI / non CNS-Systemic embolism
Time Frame: 12 months
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
Time Frame: 12 months

Assessment of the quality of life of patients using a scoring questionnaire adapted to the living conditions of the Algerian population.

The scoring varies between the lowest score of 12 and highest of 48. Change in quality of life score during the follow-up period will be evaluated by comparing the mean values.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beker Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pr Aoudia Yazid, EPH Tipaza
  • Study Chair: Pr ADJEROUD Naima, Faculty of Medicine of Algiers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TROMBIX.DZ _version 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings