ARTEMIS

Effects of ziltivekimab versus placebo on cardiovascular outcomes inpatients with acute myocardial infarction

01/10/2024 to 31/12/2032

This is an interventional, randomised, parallel-group, double-blind, placebo-controlled, multicentre, multi-national cardiovascular outcome trial (CVOT) designed to evaluate the effects of ziltivekimab 15 mg versus placebo (randomised 1:1), both added to standard of care, on CV outcomes in participants with AMI (NSTEMI/STEMI) and angiographic evidence of type 1 MI.
Participants will be stratified by STEMI/NSTEMI. The initial dose will be a loading dose of ziltivekimab 30 mg s.c./placebo to be administered as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for STEMI, and latest within 72 hours of hospitalisation for NSTEMI, followed by ziltivekimab 15 mg s.c./placebo once-monthly during the treatment period. The study consists of 3 periods: a screening period (up to 36 hours of hospitalisation for STEMI, and up to 72 hours of hospitalisation for NSTEMI), followed by a treatment period and a 3-month follow-up period after end of treatment (study duration estimated up to 25 months).