Charles Nicolle hospital
Tunis, 1006, Tunisia
NCT Number: NCT06862726
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 4
Tunis, 1006, Tunisia
Atrial fibrillation (AF) is the most common heart rhythm disorder with an estimated global prevalence of between 1 and 2%. It is a serious pathology that considerably increases morbidity and mortality. Thromboembolic events are a major complication .
Thus, effective anticoagulation is one of the major pillars of the management of atrial fibrillation. This anticoagulation was for a long time based on vitamin K antagonists (VKAs) which have proven their effectiveness in significantly reducing the risk of thromboembolic complications. However, VKAs have several drawbacks, mainly related to their narrow therapeutic range, their high inter-individual variability and their multiple drug interactions. As a result, the use of VKAs is restrictive because of the need for a delicate, regular and individual adjustment of the effective dose based on the result of the INR (need for regular and close biological monitoring) .
Since 2007, a new class of oral anticoagulant encompassing direct oral anticoagulants has emerged and is increasingly beginning to take the place of VKAs in several pathologies, including AF. Indeed, DOACs are currently the first-line treatment during AF thanks to the results of randomized controlled clinical trials that have proven an efficacy at least equivalent to VKA without increasing the risk of serious bleeding. In addition, DOACs are simpler to use compared to VKAs because of their predictable pharmacodynamics and pharmacokinetics, which make it possible to use a fixed dose and dispense with biological monitoring of their plasma levels in the majority of cases.
However, it seems that there is a significant inter- and intra-individual variability related to the use of DOACs. In addition, the theory of a single dose and the non-need for monitoring is beginning to be debated. Indeed, the indications requiring an AOD assay seem to be broadening. Recently, studies have been identified in the literature that are interested in assessing the impact of the maximum and residual activity of DOAC on its efficacy and safety. Despite significant results, especially in relation to the fluctuation of residual activity, there are so far no strong conclusions of a high level of evidence that can rule on the usefulness of adjusting the dose according to the dosage of activity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
This arm contain 40 pateints treated by VKA,. PT-INR dosage will be performed.
Time frame: 6 months
The patient will attend an initial appointment between 2 and 4 weeks to undergo sampling and receive their samples, followed by further appointments at 3 and 6 months. During these visits, samples will be collected to measure the anti-Xa activity of rivaroxaban and apixaban.
Each sampling will occur in two steps: the first sample will be taken before the morning dose to measure anti-Xa activity at the trough (or nadir), and the second sample will be collected 2 hours later to determine the peak (or maximum value reached). The results will be expressed in nanograms per milliliter (ng/mL).
Les Laboratoires des Médicaments Stériles
Industry
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
Acronym: APIXA-Xa
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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