Home › Trials › NCT06118281

Evaluating Ziltivekimab for Heart Attack Treatment

ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction

Phase 3 Interventional Novo Nordisk A/S · NCT06118281

This study is testing if a new medication called ziltivekimab can help people who have had a heart attack by reducing their chances of having more heart problems or strokes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment10000 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Drugs / interventionsziltivekimab
Locations970 sites (Alexander City, Alabama and 969 other locations)
Trial IDNCT06118281 on ClinicalTrials.gov

What this trial studies

This research evaluates the effectiveness of ziltivekimab, an investigational medication, in treating individuals who have experienced a heart attack. Participants will be randomly assigned to receive either ziltivekimab or a placebo, with the aim of determining if ziltivekimab can reduce the risk of subsequent heart disease and prevent future heart attacks or strokes. The treatment involves monthly injections for a duration of approximately two years. The study is designed to gather data on the safety and efficacy of ziltivekimab compared to a non-active treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for an acute myocardial infarction with specific diagnostic criteria.

Not a fit: Patients who do not meet the inclusion criteria for acute myocardial infarction or those with contraindications to the study medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of further heart attacks and strokes in patients who have suffered an acute myocardial infarction.

How similar studies have performed: While ziltivekimab is a novel treatment, similar studies evaluating new therapies for heart attack recovery have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key inclusion:

* Age 18 years or above at the time of signing the informed consent.
* Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities.
* ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation, at the investigator's discretion.

  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 0.25 (millivolt) mV in men less than 40 years, greater than or equal 0.2 mV in men greater than or equal 40 years, or greater than or equal 0.15 mV in women in leads V2-V3; and/or greater than or equal 0.1 mV in all other leads.

OR

* Non-ST-segment myocardial infarction with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation, at the investigator's discretion. b) Rise and/or fall in car-diac troponin I or T with at least one value above the 99th percentile upper reference limit.
* Possibility for both randomisation and administration of the loading dose of study intervention as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 72 hours of hospitalisation (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 ongoing glucose-lowering agent(s). d)Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than or equal to 15 and less than 60 milliliter per minute per 1.73 square meter (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 patients only: anterior MI at index acute myocardial infarction (AMI)

Key exclusion:

* Use of fibrinolytic therapy for treatment of the current AMI.
* Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV.
* Ongoing haemodynamic 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: a) eGFR less than 15 mililitre per minute per 1.73 m\^2. b) Chronic haemodialysis 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 eval-uation). c) Jaundice (clinical evaluation). d) Previous oesophageal/gastric variceal bleeding. c) 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 randomisation or as 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 randomisation. 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).

Where this trial is running

Alexander City, Alabama and 969 other locations

+920 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiovascular RiskAcute Myocardial Infarction
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.