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Apixaban Versus Rivaroxaban in Non Valvular Atrial Fibrillation

NCT06862726 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Non Valvular Atrial Fibrillation

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.

Sponsors & Collaborators

  • Les Laboratoires des Médicaments Stériles

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862726 on ClinicalTrials.gov