What is ziltivekimab studying for heart attack patients?

Ziltivekimab is being studied to see if it can reduce heart disease progression and prevent new heart attacks or strokes in people who have been hospitalized for a heart attack. This Phase 3 trial, sponsored by Novo Nordisk A/S, compares ziltivekimab to a placebo along with standard care to better understand its effects on cardiovascular outcomes.

Who may be eligible for this heart attack clinical trial?

Adults aged 18 and older who have been hospitalized for a recent heart attack confirmed by specific heart imaging and treatment are eligible. Both men and women may participate. Important factors include the timing of treatment after hospital admission and certain health conditions like diabetes or prior heart events. Please review eligibility criteria for more details.

Is there any cost to participate in this heart attack clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06118281

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

Led by Novo Nordisk A/S · Updated on 2026-04-14

10000

Participants Needed

970

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

CONDITIONS

Brief Title

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or above at the time of signing the informed consent.
Hospitalisation for acute myocardial infarction confirmed by invasive angiography with percutaneous coronary intervention capabilities.
For STEMI: symptom onset within 12 hours before hospitalisation with specific ECG changes.
For NSTEMI: symptom onset within 24 hours before hospitalisation and elevated cardiac troponin.
Ability to receive study intervention loading dose within 36 hours of hospitalisation for STEMI and within 72 hours for NSTEMI.
Presence of at least one risk factor such as prior MI, prior coronary revascularisation, diabetes on glucose-lowering treatment, chronic kidney disease (eGFR ≥15 and <60 mL/min/1.73 m²), prior ischemic stroke, carotid or peripheral artery disease, multivessel coronary artery disease, or anterior MI for STEMI patients only.

You will not qualify if you...

Use of fibrinolytic therapy for current acute myocardial infarction.
Chronic heart failure classified as New York Heart Association Class IV.
Ongoing haemodynamic instability including Killip Class III or IV or sustained symptomatic low blood pressure (systolic <90 mmHg).
Severe kidney impairment (eGFR <15 mL/min/1.73 m²) or on dialysis.
Known alanine aminotransferase greater than 8 times the upper limit of normal.
Severe liver disease including hepatic encephalopathy, ascites, jaundice, variceal bleeding, or cirrhosis.
Major surgery or major endoscopic procedure within past 60 days or planned at randomisation.
Active infection or suspicion of infection.
Known acute or chronic hepatitis B or C.
Untreated latent tuberculosis or unwillingness to undergo treatment if latent TB is confirmed.

Research Team

Novo Nordisk

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