Clinical trial NCT06184204: Observational Study:Safety,Efficacy and Quality of Life of Patients With Atrial Fibrillation, Treated With Trombix®
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).
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: real life
observational
safety
efficacy
Lead sponsor: Beker Laboratories
Sponsor class: INDUSTRY
First posted: 2023-12-28
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects in the study were enrolled from different centers (public and private sectors) across different regions in the country; East, Center and West of Algeria.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of reported Serious Adverse Effects linked to Trombix ®
timeFrame: 12 months
Secondary outcomes:
measure: Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion
timeFrame: 12 months
measure: Minor hemorrhages linked to Trombix®
timeFrame: 12 months
measure: Incidence of any adverse effects
timeFrame: 12 months
measure: Incidence of Trombix® treatment interruptions during 12 months of follow-up
timeFrame: 12 months
measure: Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up
timeFrame: 12 months
measure: Incidence of severe thromboses: ischemic stroke / MI / non CNS-Systemic embolism
timeFrame: 12 months
measure: Quality of life score
timeFrame: 12 months
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Boumaaza Private healthcare
city: Algiers
country: Algeria
facility: CHU Mustapha
city: Annaba
country: Algeria
facility: BEDAI private healthcare
city: Annaba
country: Algeria
facility: Berboucha
city: Batna
country: Algeria
facility: Boudjelal private healthcare
city: Biskra
country: Algeria
facility: OKBI Private healthcare
city: Blida
country: Algeria
facility: KHAITER Private healthcare
city: Constantine
country: Algeria
facility: AOUICHE private healthcare
city: Constantine
country: Algeria
facility: HAMDI private healthcare
city: M'Sila
country: Algeria
facility: Mouffok private healthcare
city: Oran
country: Algeria
facility: Ali Lahmar private healthcare
city: Oran
country: Algeria
facility: CHU Oran
city: Oran
country: Algeria
facility: EID private healthcare
city: Sidi Bel Abbès
country: Algeria
facility: Sebbagh Private Healthcare
city: Tipaza
country: Algeria
facility: EPH Tipaza
city: Tizi Ouzou
country: Algeria
facility: Fernane private healthcare
city: Tlemcen
country: Algeria
facility: NASSOUR private healthcare
Study officials:
affiliation: EPH Tipaza
name: Pr Aoudia Yazid
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine of Algiers
name: Pr ADJEROUD Naima
role: STUDY_CHAIR
References: