FXIASCO

 

Titre de l’étude : Impact of FXI(a) inhibitor (abelacimab, asundexian and milvexian) effects on routine and specialized coagulation assays: a multicenter French study

Type d’étude : étude biologique

Investigateur principal : Georges JOURDI

Mail de contact : georges.jourdi@aphp.fr

Descriptif très sommaire de l’étude : Inhibitors of coagulation factor XI (FXI activated (a) or not) are under development as novel anticoagulant drugs. Parenteral monoclonal antibody blocking FXI activation (abelacimab) and oral small molecules inhibiting the active site of FXIa (milvexian, asundexian) have completed phase 2 clinical trials and several phase 3 trials are ongoing or planned to evaluate their efficacy and safety in different clinical settings. They will incorporate our daily clinical practice in the upcoming couple of years. These molecules may affect many coagulation tests performed for patients as part of their clinical assessment, especially, in case of bleeding or emergency invasive procedures. Thus, there is a need for clinicians to know whether the wide range of routine and specialized coagulation assays are influenced by FXI(a) inhibitors use and to which extent. The aim of this French multicenter study is to assess the effects of FXI(a) inhibitors on routine and specific coagulation assays and provide good laboratory recommendations for the accurate interpretation of hemostasis diagnostic assays in patients receiving these drugs. It will also allow the comparison of the pharmacodynamics of the different molecules in development.

N° d’enregistrement : non-applicable

Date de début : novembre 2024

Durée ou date de fin : novembre 2025

Type d’étude : académique

Inclusion possible : oui

Catégorie : simple aveugle