Actively Recruiting
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
Led by Novo Nordisk A/S · Updated on 2026-03-11
332
Participants Needed
20
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is testing the effect of ziltivekimab on reducing plaque in the blood vessels of the heart, specifically aiming to manage or reduce atherosclerotic plaque. The purpose of the study is to determine whether ziltivekimab can effectively reduce this plaque. Participants will either receive ziltivekimab (the active medicine) or a placebo (a dummy medicine with no effect on the body), with the treatment assignment decided by chance. It is important to note that ziltivekimab is not yet approved in any country or region worldwide; therefore, it is a new medicine that doctors cannot prescribe. The study will last for about 15 months.
CONDITIONS
Official 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 obtained before any study-related activities
- Age 18 years or above
- Acute myocardial infarction treated with percutaneous coronary intervention (PCI)
- At least one coronary segment treated with PCI
- Acute STEMI with symptom onset within 24 hours and ECG changes meeting specific criteria
- NSTEMI with rise and/or fall in cardiac troponin above the 99th percentile
- At least two major native coronary arteries with 20-50% diameter reduction suitable for imaging
- Study vessels accessible to imaging catheters and suitable for intracoronary imaging
- No previous PCI in the study segment
- Hemodynamic stability allowing nitroglycerine administration during imaging
- Ability to understand the study and provide informed consent
- Willingness to undergo follow-up intracoronary imaging
- Randomisation and loading dose administration possible within 48 hours after PCI
You will not qualify if you...
- Known or suspected hypersensitivity to study interventions or related products
- Allergy to contrast medium, heparin, aspirin, ticagrelor, or prasugrel
- Previous participation in this study
- Female of childbearing potential
- Participation in other interventional or imaging studies within 30 days or during hospitalization
- Conditions jeopardizing safety or protocol compliance
- Left-main coronary artery disease with \u226550% lumen reduction
- Severe three-vessel coronary artery disease requiring revascularization or untreatable
- History of coronary artery bypass surgery
- TIMI flow <2 in infarct-related artery after PCI
- Unstable clinical status including hemodynamic or electrical instability
- Significant coronary calcification or tortuosity preventing imaging
- Uncontrolled cardiac arrhythmia in past 3 months
- Severe kidney impairment or dialysis
- Active liver disease or hepatic dysfunction
- Use of anti-IL-6 products or systemic immunosuppressive drugs
- Active infection or major hematologic, metabolic, or endocrine dysfunction
- History of recurrent serious infections in past 12 months
- Use of preventive systemic antibiotics, antivirals, or antifungals
- Low neutrophil or platelet counts below set thresholds
- Elevated liver enzymes above defined limits unless due to current AMI
- Known hepatitis B or C
- Planned surgery within 12 months
- History of cancer within 5 years except certain treated cancers
- Life expectancy less than 2 years
- Risk factors or history of latent tuberculosis
- HIV diagnosis
- History of gastrointestinal perforation or active diverticulitis
- Inflammatory bowel disease active in past 12 months
- History or anticipation of bone marrow or solid organ transplant
- Recent live or attenuated-live vaccine use
- Recent major surgery or planned major surgery at randomisation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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