Actively Recruiting
Effects of Ziltivekimab Versus Placebo on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction Using Advanced Imaging Techniques
Led by Novo Nordisk A/S · Updated on 2026-03-11
332
Participants Needed
20
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can reduce plaque buildup in the heart's blood vessels in people who have had a heart attack. The study focuses on patients with acute myocardial infarction and compares the effects of ziltivekimab against a placebo. This phase 3 trial aims to understand the impact of ziltivekimab on heart vessel plaque over about 15 months. Participants will be randomly assigned to receive either ziltivekimab or a placebo, both given as monthly injections under the skin for 12 months alongside standard heart care. The study uses advanced imaging techniques like intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography to monitor changes in the arteries. The treatment is administered shortly after participants undergo certain heart procedures. During the study, participants will undergo detailed heart imaging and blood tests at the start, at 4 weeks, and at 52 weeks to measure changes in plaque volume and inflammation markers. Researchers will monitor heart-related events like heart attacks, strokes, and deaths throughout the year. The study includes adherence tracking and safety monitoring to evaluate the treatment's effects and any risks over the full duration.
CONDITIONS
Brief Title
A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent given before any study procedures
- Age 18 years or older at time of consent
- Recent acute myocardial infarction treated with percutaneous coronary intervention (PCI)
- At least one coronary segment treated and at least two major native coronary arteries suitable for imaging
- Hemodynamically stable and able to undergo repeated imaging with nitroglycerine
- Able to understand study requirements and provide informed consent
- Willing to have follow-up intracoronary imaging
- Able to be randomized and receive treatment within 48 hours after PCI
You will not qualify if you...
- Known or suspected allergy to study drugs or related products
- Allergy to contrast medium, heparin, aspirin, ticagrelor, or prasugrel
- Previous participation in this study (randomized)
- Female of childbearing potential
- Participation in other interventional or imaging studies within past 30 days
- Any condition risking safety or protocol compliance as judged by investigator
- Left-main coronary artery disease (≥50% narrowing)
- Severe three-vessel coronary artery disease
- History of coronary artery bypass surgery
- Poor blood flow (TIMI flow <2) after PCI
- Unstable clinical status including severe heart rhythm problems
- Severe kidney impairment or dialysis
- Active liver disease or dysfunction
- Use or anticipated use of anti-interleukin-6 or systemic immunosuppressive drugs
- Active infection or serious metabolic/endocrine dysfunction
- Recent serious infections or preventive systemic antibiotic/antiviral/antifungal use
- Low neutrophil or platelet counts
- Elevated liver enzymes beyond specified limits
- Known hepatitis B or C infection
- Planned surgery within 12 months
- Recent history of cancer with some exceptions
- Estimated life expectancy less than 2 years
- Risk factors or history of latent tuberculosis
- HIV diagnosis
- History of gastrointestinal perforation or recent active diverticulitis
- Recent inflammatory bowel disease activity
- History or planned organ transplant
- Recent or planned live vaccine use
- Recent major surgery or planned surgery related to heart attack
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive ziltivekimab or placebo subcutaneously once monthly for 12 months along with standard of care.
Monthly visits for 12 months
Duration - Up to end of study at 52 weeks
Participants are monitored for safety and outcomes after completing treatment.
Follow-up visits at week 4 and week 52
Trial Site Locations
Total: 20 locations
1
Medizinische Universität Wien
Vienna, Austria, 1090
Not Yet Recruiting
2
Aalborg Universitetshospital Hjertemedicinsk Afdeling
Gistrup, Denmark, 9260
Not Yet Recruiting
3
Rigshospitalet - Kardiologisk Forskningsenhed
København Ø, Denmark, 2100
Not Yet Recruiting
4
Azienda Ospedaliera San Giovanni Addolorata
Rome, Lazio, Italy, 00184
Not Yet Recruiting
5
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, Italy, 24127
Not Yet Recruiting
6
DAI Scienze Mediche - UOC Endocrinologia
Messina, Sicily, Italy, 98124
Not Yet Recruiting
7
Presidio Ospedaliero di Rivoli
Rivoli, To, Italy, 10098
Not Yet Recruiting
8
Ospedale Policlinico San Martino
Genova, Italy, 16132
Not Yet Recruiting
9
AOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia
Novara, Italy, 28100
Not Yet Recruiting
10
Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche
Orbassano, Italy, 10043
Not Yet Recruiting
11
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Rome, Italy, 00168
Not Yet Recruiting
12
IRCCS Policlinico San Donato
San Donato Milanese, Italy, 20097
Not Yet Recruiting
13
Radboudumc
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
14
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
15
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Not Yet Recruiting
16
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Not Yet Recruiting
17
Universitäres Herzzentrum
Basel, Switzerland, 4031
Actively Recruiting
18
Inselspital-Universitätsklinik für Kardiologie
Bern, Switzerland, 3010
Actively Recruiting
19
HUG-Service de Cardiologie
Geneva, Switzerland, 1205
Not Yet Recruiting
20
LUKS-Herzzentrum
Lucerne, Switzerland, 6000
Actively Recruiting
Research Team
N
Novo Nordisk
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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