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ENROLLING BY INVITATION
NCT06862726
PHASE4

Apixaban Versus Rivaroxaban in Non Valvular Atrial Fibrillation

Sponsor: Les Laboratoires des Médicaments Stériles

View on ClinicalTrials.gov

Summary

The investigators will first measure the maximum concentration (after 2 hours of intake) and the residual concentration (just before the next intake) after at least 15 consecutive days of treatment. In order to be able to study the stability of the anti-Xa activity of Apixaban vs Rivaroxaban, as well as their impact on the risk of thromboembolic events or hemorrhagic events, clinical follow-up and a determination of maximum and residual activity are necessary, ideally at 3 to 6 months (compared to studies carried out in the literature). This evaluation would be made according to a multivariate analysis taking into consideration the other clinical-biological data relating to the patient, namely renal function, liver function, CHA2DS2-VASc score, HAS-BLEED score, treatment compliance, etc.

Official title: Study of the Inter- and Intra-individual Variability of Anti-Xa Activity of Apixaban Versus Rivaroxaban Versus Control Arm During Non-valvular Atrial Fibrillation: Evaluation of Stability and Clinical Impact

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-12-01

Completion Date

2025-12-31

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

DRUG

Anti Xa dosage

VKA: quadriseparable tablet Apixaban: 5 mg twice daily or 2.5 twice daily Rivaroxaban: 20 mg once a day or 15 mg once a day

DRUG

Dosage of PT-INR

This arm contain 40 pateints treated by VKA,. PT-INR dosage will be performed.

Locations (1)

Charles Nicolle hospital

Tunis, Tunisia