ARTEMIS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction

To demonstrate the superiority of a loading dose of ziltivekimab 30 mg s.c. vs placebo followed by ziltivekimab 15 mg s.c. once monthly versus placebo, both added to standard of care, in reducing the risk of MACE in participants with AMI. 

For more information, visit: https://clinicaltrials.gov/study/NCT06118281

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

1.  Hospitalisation for acute myocardial infarction with evidence of type 1 MIb,13 by invasive angiography performed at site with PCI capabilities.

•  ST-segment elevation myocardial infarction with all the following:
  • Relevant symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation or during hospitalisation.
  • ECG-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads ≥0.25 mV in men <40 years, ≥0.2 mV in men ≥40 years, or ≥0.15 mV in women in leads V2-V3; and/or ≥0.1 mV in all other leads.

Or

• Non-ST-segment myocardial infarction with all the following:
   
  • Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation or during hospitalisation.
  • Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.

2.  Possibility for randomisation as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 48 hours of hospitalisation (time 0) for NSTEMI.

3.  The documented presence of a coronary stent on the coronary angiogram performed for the current (index) AMI is acceptable to define prior coronary revascularisation.

1. Known or suspected hypersensitivity to study intervention or related products.
2. Previous participation in this study. Participation is defined as randomisation.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method (adequate contraceptive measures as required by local regulation or practice)
4. Use of fibrinolytic therapy for treatment of the current AMI.
5. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV
6. History of recurrent serious infections (infections leading to hospitalisation or use of i.v. antibiotics) within the past 12 months, at the discretion of the investigator.