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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06184204
Other study ID # TROMBIX.DZ _version 2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 18, 2023
Est. completion date April 2025

Study information

Verified date March 2024
Source Beker Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date April 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Trombix® (Rivaroxaban)
20mg or 15 mg as per the doctor's prescription

Locations

Country Name City State
Algeria Boumaaza Private healthcare Algiers
Algeria CHU Mustapha Algiers
Algeria BEDAI private healthcare Annaba
Algeria Berboucha Annaba
Algeria Boudjelal private healthcare Batna
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 Abbès
Algeria EPH Tipaza Tipaza
Algeria Fernane private healthcare Tizi Ouzou
Algeria NASSOUR private healthcare Tlemcen

Sponsors (1)

Lead Sponsor Collaborator
Beker Laboratories

Country where clinical trial is conducted

Algeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion Description the epidemiological characteristics of the patients: demographic data, pathological history, clinical profile at inclusion 12 months
Secondary Minor hemorrhages linked to Trombix® Assessment of the Incidence of minor hemorrhages linked to Trombix® leading to definitive cessation of treatment 12 months
Secondary Incidence of any adverse effects Assessment of the incidence rate of any adverse effects 12 months
Secondary Incidence of Trombix® treatment interruptions during 12 months of follow-up Assessment of the percentage of patients who stopped Trombix® treatment during the 12 months of follow-up 12 months
Secondary Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up Identification of the causes behind stopping treatment with Trombix® 12 months
Secondary Incidence of severe thromboses: ischemic stroke / MI / non CNS-Systemic embolism Assessment of the occurrence rate of ischemic stroke and the occurrence rate of systemic embolism during the duration of the study 12 months
Secondary Quality of life score 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
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