A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE

Titre officiel

A Multicentre, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE

Sommaire:

Il s’agit d’une étude ouverte de phase III, multicentrique, à répartition aléatoire, et en insu comparant l’effet de l’abelacimab par rapport à l’apixaban sur la récidive de la thromboembolie veineuse (TEV) et les saignements chez les patients présentant une TEV associée au cancer (ASTER).

Description de l'essai

Primary Outcome:

• Time to first event of centrally adjudicated VTE recurrence consisting of new proximal deep venous thrombosis, new pulmonary embolism (PE) or fatal PE, including unexplained death for which PE cannot be ruled out

Secondary Outcome:

• Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events
• Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding

Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. The two most common treatments today are low molecular weight heparin (LMWH) and direct anticoagulants (DOACs), in which each has limitations. DOACs are administered orally and are seen as a more convenient alternative though associated with bleeding risk; further, some cancer patients have difficulty swallowing or develop vomiting which leads to unpredictable pharmacodynamic effects with oral therapy. The ANT-007 study will compare treatment with abelacimab monthly administration to apixaban twice daily administration over a 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months

Voir cet essai sur ClinicalTrials.gov