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

Summary

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.

Conditions

• Coronary Artery Disease
• Acute Myocardial Infarction (AMI)
• Coronary Atherosclerosis of Native Coronary Artery

Interventions

DRUG

Ziltivekimab

Ziltivekimab is administered subcutaneously (i.e., under the skin) once per month added to standard of care.

DRUG

Placebo

Placebo is administered subcutaneously (i.e., under the skin) once per month added to standard of care.

Sponsors & Collaborators

• Novo Nordisk A/S

  collaborator INDUSTRY

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Cardialysis B.V.

  collaborator INDUSTRY

• ECRI bv

  lead INDUSTRY

Principal Investigators

• Lorenz Räber, MD, PhD · Cardiology Department, Bern University Hospital, Inselspital Bern, Switzerland

• Ernest Spitzer, MD · European Cardiovascular Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-19

Primary Completion

2028-09-01

Completion

2028-12-01

Countries

• Switzerland

Study Locations