Actively Recruiting
Effects of Ziltivekimab Versus Placebo on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction Using Advanced Intravascular Imaging
Led by ECRI bv · Updated on 2026-03-23
332
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
E
ECRI bv
Lead Sponsor
N
Novo Nordisk A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a new medication called ziltivekimab can help improve artery health in patients with coronary artery disease (CAD) who have recently had a heart attack (acute myocardial infarction). Despite existing treatments, many patients remain at risk for further heart attacks and hospitalizations. This study focuses on the role of inflammation in artery blockages and aims to see if reducing inflammation with ziltivekimab affects the buildup and characteristics of plaques in the coronary arteries. The study is a randomized, double-blind, placebo-controlled trial where participants receive either ziltivekimab or a placebo through a once-monthly injection under the skin, in addition to their standard heart attack treatments. The first dose is given as soon as possible, no later than 48 hours after a heart procedure called PCI. The treatment lasts for about one year. Advanced imaging techniques like intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography will be used to examine changes in the arteries and plaque composition over time. During the approximately 15-month study period, participants will undergo regular assessments including imaging scans of their coronary arteries to measure plaque volume, lipid content, and fibrous cap thickness. Researchers will monitor changes from the start of treatment to the end of the study. Safety will be closely observed, and participants will continue to receive their usual care alongside the study treatment. The main goal is to determine if ziltivekimab can reduce artery narrowing and stabilize plaques to lower the risk of future heart problems.
CONDITIONS
Brief Title
Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 treated with PCI
- At least two major native coronary arteries suitable for intracoronary imaging immediately after PCI
You will not qualify if you...
- Known or suspected hypersensitivity to study treatments or related products
- Known allergy to contrast medium, heparin, aspirin, ticagrelor, or prasugrel
- Female of childbearing potential
- Left-main coronary artery disease
- Three-vessel coronary artery disease
- History of coronary artery bypass surgery
- TIMI flow less than 2 in the infarct-related artery after PCI
- Unstable clinical status including hemodynamic or electrical instability
- Significant coronary calcification or tortuosity preventing imaging evaluation
- Uncontrolled cardiac arrhythmia
- Severe kidney impairment
- Active liver disease or hepatic dysfunction
- Current or anticipated use of anti-IL-6 products during the study
- Use or anticipated chronic use of systemic immunosuppressive or anti-rheumatic drugs during the study
- Known or suspected active infection or major hematologic, metabolic, or endocrine dysfunction
- History of recurrent serious infections
- Use of preventive systemic antibiotics, antivirals, or antifungals
- Known acute or chronic hepatitis B or C
- Planned surgery within 12 months from screening
- History of cancer within the past 5 years except certain low-risk types
- Estimated life expectancy less than 2 years
- Recent live or attenuated-live vaccine use within 4 weeks or planned during treatment
- Major cardiac surgery within past 60 days or planned as treatment for current infarction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive monthly subcutaneous injections of either Ziltivekimab or placebo in addition to standard care, starting as early as possible and within 48 hours after their PCI procedure.
Monthly visits for injections during the treatment period
Trial Site Locations
Total: 1 location
1
Bern University Hospital, Inselspital Bern
Bern, Switzerland
Actively Recruiting
Research Team
A
Anita Dekker
E
Ernest Spitzer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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