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

Sponsor
ECRI bv
Study ID
NCT07276282
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 19, 2025
Status verified
Mar 2026
Primary completion
Sep 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
332 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ziltivekimab Arm
    Participants will receive Ziltivekimab subcutaneously once per month
  • Placebo Comparator: Placebo Arm
    Participants will receive placebo subcutaneously once per month

Primary Outcome Measure

Change in percent atheroma volume [ Time Frame: From randomization (week 0) to end-of-study (52-week) ]

Central Contacts

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