Trials Sponsors Conditions Drugs Pricing

Conditions

Atrial Fibrillation

Keywords

real lifeobservationalsafetyefficacy

Outcome Measures

Primary Outcomes (1)

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 Outcomes (7)

Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion
12 months
Minor hemorrhages linked to Trombix®
12 months
Incidence of any adverse effects
12 months
Incidence of Trombix® treatment interruptions during 12 months of follow-up
12 months
Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up
12 months
+2 more secondary outcomes

Study Arms (1)

Patients with confirmed diagnosis of Atrial fibrillation

male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation

Drug: Trombix® (Rivaroxaban)

Interventions

Trombix® (Rivaroxaban)Drug

20mg or 15 mg as per the doctor's prescription

Also known as: Trombix®

Patients with confirmed diagnosis of Atrial fibrillation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Patient, male or female, aged ≥ 19 years.

Sponsors & Collaborators

Beker Laboratories
Industrylead

Study Sites (17)

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

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-Ring

Study Officials

Pr Aoudia Yazid
EPH Tipaza
PRINCIPAL INVESTIGATOR
Pr ADJEROUD Naima
Faculty of Medicine of Algiers
STUDY CHAIR

Enrollment

398 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 28, 2023

Study Start

December 18, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Patients with confirmed diagnosis of Atrial fibrillation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Patients with confirmed diagnosis of Atrial fibrillation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations