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Completed

NCT Number: NCT06184204

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boumaaza Private healthcare, Algiers, Algeria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trombix® (Rivaroxaban)

Drug

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

Other names: Trombix®

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Incidence of any adverse effects

    Time frame: 12 months

    Assessment of the incidence rate of any adverse effects

  4. 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

  5. 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®

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Beker Laboratories

Industry

Registry information

Official study title

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

Acronym: TROMBIXDZ

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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