LIBREXIA ACS
A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome (Librexia ACS)
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 14,194 patients with a recent acute coronary syndrome, milvexian added to antiplatelet therapy was compared with placebo on cardiovascular death, myocardial infarction or ischaemic stroke.
N
14 194
Schéma
International, multicentre, randomised, double-blind (quadruple-masked), placebo-controlled, event-driven phase 3 trial; 1:1 allocation to milvexian or matched placebo on top of investigator-chosen standard antiplatelet therapy (SAPT or DAPT); randomisation stratified by planned type and duration of antiplatelet therapy; follow-up planned until 875 primary-endpoint events (up to about 3.5 years)
Critère
Time to first occurrence of the composite of cardiovascular death, myocardial infarction or ischaemic stroke