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.
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.
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.
Parallel
Ziltivekimab
DrugZiltivekimab is administered subcutaneously (i.e., under the skin) once per month added to standard of care.
Placebo
DrugPlacebo is administered subcutaneously (i.e., under the skin) once per month added to standard of care.
Change in percent atheroma volume
Change in percent atheroma volume (PAV) as determined by greyscale intravascular ultrasound (IVUS) in matched regions of interest. Theoretical change is between -100% to +100%. Typical range around -2% to +2%. A lower (more negative) change in PAV is better.
Maximum lipid core burden index
Change in maximum lipid core burden index (LCBI) in any 4-mm segment (maxLCBI4mm) as determined by NIRS in matched regions of interest. Theoretical range is between -1000 to +1000. Typical range around -250 to +250. A lower (more negative) change is better.
Minimal fibrous cap thickness
Change in minimal fibrous cap thickness as determined by optical coherence tomography (OCT) in matched regions of interest. Theoretical range is between -500 µm to +500 µm. Typical range around -50 µm to +110 µm. A higher (positive) change is better; it indicates fibrous cap thickening (increased plaque stability).
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ECRI bv
Lead sponsor
Novo Nordisk A/S
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Cardialysis B.V.
Collaborator
