ARTEMIS

Currently Recruiting: Participants

Study Drug/Intervention: Ziltivekimab/Placebo

Anticipated Sample Size: 10,000 globally

Recruitment Started: June 2024

Anticipated Recruitment End Date: February 2026

ClinicalTrials.gov ID: NCT06118281

Study Objective

Compare Ziltivekimab to placebo in patients admitted to hospital for AMI (STEMI/NSTEMI) in reduction of heart disease development thereby preventing new heart attacks or strokes.

Inclusion Criteria

• Age 18 years or above at the time of signing the informed consent
• Hospitalization for acute myocardial infarction with evidence of type 1 MI (myocardial infarction) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities
• ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischemia within 12 hours before hospitalization or during hospitalization, b) Electrocardiogram (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 greater than or equal to 0.25 millivolt (mV) in men less than 40 years, greater than or equal to 0.2 mV in men greater than or equal to 40 years, or greater than or equal to 0.15 mV in women in leads V2-V3; and/or greater than or equal to 0.1 mV in all other leads OR - Non-ST-segment myocardial infarction (NSTEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischemia within 24 hours before hospitalization or during hospitalization, b) Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit
• Possibility for randomization as early as possible after an invasive procedure, and latest within 36 hours of hospitalization (time 0) for STEMI, and latest within 48 hours of hospitalization (time 0) for NSTEMI
• Presence of at least one of the following criteria (confirmed based on the participant's medical records and/or medical history interview): a) Any prior MI, b) Prior coronary revascularisation, c) Diabetes mellitus treated with a glucose-lowering agent(s), d) Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than equal to 15 and less than 60 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), e) Prior ischaemic stroke, f) Known carotid disease or peripheral artery disease in the lower extremities, g) Multivessel coronary artery disease (current/prior), h) For STEMI participants only: anterior MI at index AMI

Exclusion Criteria

• Use of fibrinolytic therapy for treatment of the current AMI (acute myocardial infarction)
• Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV
• Ongoing hemodynamic instability defined as any of the following: a) Killip Class III or IV, b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg))
• Severe kidney impairment defined as any of the following: Chronic hemodialysis or peritoneal dialysis
• Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN)
• Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation), b) Previously known or current ascites (clinical evaluation), c) Jaundice (clinical evaluation), d) Previous oesophageal/gastric variceal bleeding, e) Known hepatic cirrhosis
• Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery [CABG]), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomization or as a treatment for the current AMI (CABG). Deferred (staged) percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed
• Clinical evidence of, or suspicion of, active infection at the discretion of the investigator
• Known (acute or chronic) hepatitis B or hepatitis C
• History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomization, b) Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2)

Novo Nordisk

• PI: Adrian Hernandez, MD and Jennifer Rymer, MD
• PL: Sharon Califf