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Apixaban Versus Rivaroxaban in Non Valvular Atrial Fibrillation
Sponsor: Les Laboratoires des Médicaments Stériles
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
Conditions
Interventions
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
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