Atrial FibrillationTROMBIXDZNCT06184204
Observational Study:Safety,Efficacy and Quality of Life of Patients With Atrial Fibrillation, Treated With Trombix®
An observational study of Atrial Fibrillation, run by Beker Laboratories at 17 sites in Algeria.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Trombix® (Rivaroxaban)
- How many people
- 398 participants
- Where
- 17 sitesAlgeria
- Study dates
- 18 Dec 2023to 22 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Algeria17 sites
Boumaaza Private healthcare
Algiers
CHU Mustapha
Algiers
BEDAI private healthcare
Annaba
Berboucha
Annaba
Boudjelal private healthcare
Batna City
OKBI Private healthcare
Biskra
KHAITER Private healthcare
Blida
AOUICHE private healthcare
Constantine
HAMDI private healthcare
Constantine
Mouffok private healthcare
M'Sila
Ali Lahmar private healthcare
Oran
CHU Oran
Oran
EID private healthcare
Oran
Sebbagh Private Healthcare
Sidi Bel Abbes
EPH Tipaza
Tipasa
Fernane private healthcare
Tizi Ouzou
NASSOUR private healthcare
Tlemcen
About this study
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).
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Trombix® (Rivaroxaban)
- Keywords
- real life, observational, safety, efficacy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trombix® (Rivaroxaban)Drug
Also called Trombix®
20mg or 15 mg as per the doctor's prescription
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed diagnosis of Atrial fibrillation | male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation Receives: Drug: Trombix® (Rivaroxaban) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (7)
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
Measured: 12 months
Minor hemorrhages linked to Trombix®
Assessment of the Incidence of minor hemorrhages linked to Trombix® leading to definitive cessation of treatment
Measured: 12 months
Incidence of any adverse effects
Assessment of the incidence rate of any adverse effects
Measured: 12 months
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
Measured: 12 months
Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up
Identification of the causes behind stopping treatment with Trombix®
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start18 Dec 2023
- Primary completion30 Mar 2025
- Study completion22 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beker Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pr Aoudia Yazid, Principal investigator, EPH TipazaPr ADJEROUD Naima, Study chair, Faculty of Medicine of Algiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184204
- Sponsor's protocol ID
- TROMBIX.DZ _version 3
- Acronym
- TROMBIXDZ
- Status last verified
- Sep 2025
- First submitted
- 14 Dec 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06184204
- Acronym / sponsor ID
- TROMBIXDZ / TROMBIX.DZ _version 3
- Conditions
- Atrial Fibrillation
- Keywords
- real life, observational, safety, efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Beker LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 22 Jun 2025 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed diagnosis of Atrial fibrillation | – | Drug: Trombix® (Rivaroxaban)male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trombix® (Rivaroxaban)Also: Trombix®20mg or 15 mg as per the doctor's prescription | Drug | Patients with confirmed diagnosis of Atrial fibrillation |
Primary outcome
Assessment of reported Serious Adverse Effects linked to Trombix ®
Time frame: 12 months
* 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
7 secondary outcomes
Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion
Time frame: 12 months
Minor hemorrhages linked to Trombix®
Time frame: 12 months
Incidence of any adverse effects
Time frame: 12 months
Incidence of Trombix® treatment interruptions during 12 months of follow-up
Time frame: 12 months
Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up
Time frame: 12 months
Incidence of severe thromboses: ischemic stroke / MI / non CNS-Systemic embolism
Time frame: 12 months
Quality of life score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pr Aoudia Yazid principal investigator
EPH Tipaza
Pr ADJEROUD Naima study chair
Faculty of Medicine of Algiers
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Beker Laboratories at 17 sites in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of reported Serious Adverse Effects linked to Trombix ® (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.