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NCT06184204Completed

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

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
398 (actual)
First submitted
14 Dec 2023
Start date
18 Dec 2023
Primary completion date
30 Mar 2025
Lead sponsor
Beker Laboratories
NCT number
NCT06184204

What you commit to

  • Study type: Observational
  • Participants enrolled: 398
  • From 18 Dec 2023 to the primary completion date, 30 Mar 2025
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.
  • Liver injury associated with coagulopathy and clinically significant bleeding risk, including cirrhotic patients with Child Pugh score class B or C.

Other

  • Pregnancy and breast feeding

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boumaaza Private healthcare
Coordinator of this site? Confirm its status
AlgiersAlgeriaUnknown status
CHU Mustapha
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AlgiersAlgeriaUnknown status
BEDAI private healthcare
Coordinator of this site? Confirm its status
AnnabaAlgeriaUnknown status
Berboucha
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AnnabaAlgeriaUnknown status
Boudjelal private healthcare
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Batna CityAlgeriaUnknown status
OKBI Private healthcare
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BiskraAlgeriaUnknown status
KHAITER Private healthcare
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BlidaAlgeriaUnknown status
HAMDI private healthcare
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ConstantineAlgeriaUnknown status
AOUICHE private healthcare
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ConstantineAlgeriaUnknown status
Mouffok private healthcare
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M'SilaAlgeriaUnknown status
Ali Lahmar private healthcare
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OranAlgeriaUnknown status
CHU Oran
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OranAlgeriaUnknown status
EID private healthcare
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OranAlgeriaUnknown status
Sebbagh Private Healthcare
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Sidi Bel AbbesAlgeriaUnknown status
EPH Tipaza
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TipasaAlgeriaUnknown status
Fernane private healthcare
Coordinator of this site? Confirm its status
Tizi OuzouAlgeriaUnknown status
NASSOUR private healthcare
Coordinator of this site? Confirm its status
TlemcenAlgeriaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.