Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorECRI bv

About this trial

Despite improvements in the treatment, coronary artery disease (CAD) remains one of the leading causes of death worldwide. Around 20% of people who have suffered a heart attack (myocardial infarction) need to be hospitalized again within a year, and 10% experience another heart attack. Despite currently available medication, patients remain at risk of further episodes after a heart attack. Scientists have discovered that inflammation in the body plays a decisive role in the development and narrowing of arterial blockages (atherosclerosis). This study aims to investigate whether a new treatment that reduces inflammation can help improve the arteries of patients with CAD.

This study will examine whether blocking certain inflammation-related substances with a new medicinal product called ziltivekimab affects the buildup and composition of plaques (fatty deposits) in the coronary arteries. Special imaging diagnostic techniques will be used to look inside the arteries and check whether the treatment helps reduce the narrowing caused by dangerous plaques, which can lead to future heart attacks.

This is a clinical study in which participants are randomly divided into two groups (randomization): one group will receive the new treatment ziltivekimab and other group will receive a placebo (a harmless substance with no active ingredients). Both groups will continue to receive standard treatment for heart attacks. The study lasts approximately 15 months per participant.

The full scientific title of the trial is: Effects of ziltivekimab versus placebo on coronary atherosclerosis in patients with acute myocardial infarction. A study with serial multi-vessel imaging obtained using intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography techniques.

Eligibility criteria

Qualifiers

Informed consent obtained before any study-related activities.

Age 18 years or above at the time of providing informed consent.

Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with PCI.

At least two major native coronary arteries each meeting angiographic criteria for intracoronary imaging immediately following the qualifying PCI procedure.

Disqualifiers

Known or suspected hypersensitivity to study intervention(s) or related products.

Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.

Female of childbearing potential.

Left-main disease.

Trial design

Treatments tested in this trial

  • Ziltivekimab
  • Placebo

Treatment groups

332 Participants
are divided into 2 treatment groups

Sponsors and collaborators

ECRI bv

Lead sponsor

Novo Nordisk A/S

Collaborator

Insel Gruppe AG, University Hospital Bern

Collaborator

Cardialysis B.V.

Collaborator