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

Atrial Fibrillation Clinical Trial

— TROMBIXDZ  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06184204
• Other study ID #: TROMBIX.DZ _version 2
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

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