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
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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COMPLETED
398 participants
OBSERVATIONAL
2023-12-18
2025-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Beker Laboratories
INDUSTRY
Responsible Party
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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
CHU Mustapha
Algiers, , Algeria
BEDAI private healthcare
Annaba, , Algeria
Berboucha
Annaba, , Algeria
Boudjelal private healthcare
Batna City, , Algeria
OKBI Private healthcare
Biskra, , Algeria
KHAITER Private healthcare
Blida, , Algeria
AOUICHE private healthcare
Constantine, , Algeria
HAMDI private healthcare
Constantine, , Algeria
Mouffok private healthcare
M'Sila, , Algeria
Ali Lahmar private healthcare
Oran, , Algeria
CHU Oran
Oran, , Algeria
EID private healthcare
Oran, , Algeria
Sebbagh Private Healthcare
Sidi Bel Abbes, , Algeria
EPH Tipaza
Tipasa, , Algeria
Fernane private healthcare
Tizi Ouzou, , Algeria
NASSOUR private healthcare
Tlemcen, , Algeria
Countries
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Other Identifiers
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TROMBIX.DZ _version 3
Identifier Type: -
Identifier Source: org_study_id
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