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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

Effects of Ziltivekimab Versus Placebo on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-infrared Spectroscopy and Optical Coherence Tomography Imaging Study

NCT07301034•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
•Age 18 years or above at the time of providing informed consent.
•Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with percutaneous coronary intervention (PCI):
•a. Acute ST-segment elevation myocardial infarction (STEMI) with all of the following: i. Onset of relevant pain suggestive of cardiac ischemia within less than or equal to (=\<) 24h of index angiography.
•ii. Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads greater than or equal to (\>=) 0.25 millivolts (mV) in men less than (\<) 40 years, \>=0.2 mV in men \>=40 years, or \>=0.15 mV in women in leads V2-V3; and/or \>=0.1 mV in all other leads.
•Non-ST segment elevation myocardial infarction (NSTEMI), with rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.
•At least two major native coronary arteries ‡ ("study vessels") each meeting the following criteria for intracoronary imaging immediately following the qualifying PCI procedure:
•1. Angiographic evidence of a reduction in lumen diameter between \>20 and \<50 percent (%) by angiographic visual estimation.
•2. Study vessel deemed to be accessible to imaging catheters and suitable for intracoronary imaging in the proximal (50 millimeter \[mm\]) segment ("study segment").
•3. Study vessel may not be a bypass (saphenous vein or arterial) graft or a bypassed native vessel.
+5 more criteria

Exclusion Criteria

•Known or suspected hypersensitivity to study intervention(s) or related products.
•Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.
•Previous participation in this study. Participation is defined as randomisation.
•Female of childbearing potential.
•Participation in any other interventional or imaging clinical study within the past 30 days, or as parallel inclusion during the index hospitalization.
•Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
•Left-main disease, defined as \>=50 percent (%) reduction in lumen diameter of the left main coronary artery by angiographic visual estimation
•Three-vessel disease, defined as the presence of severe or significant coronary artery disease (CAD) on the basis of angiography, imaging, or physiology, in all three major epicardial territories (including major branches) that have an indication for revascularization or are too advanced to be treated.
•History of coronary artery bypass surgery
•Thrombolysis In Myocardial Infarction (TIMI) flow \<2 of the infarct-related artery after PCI
+28 more criteria

Locations (20)

Medizinische Universität Wien

Vienna, Austria

Aalborg Universitetshospital Hjertemedicinsk Afdeling

Gistrup, Denmark

Rigshospitalet - Kardiologisk Forskningsenhed

København Ø, Denmark

Azienda Ospedaliera San Giovanni Addolorata

Rome, Lazio, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

DAI Scienze Mediche - UOC Endocrinologia

Messina, Sicily, Italy

Presidio Ospedaliero di Rivoli

Rivoli, To, Italy

Ospedale Policlinico San Martino

Genova, Italy

AOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia

Novara, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche

Orbassano, Italy

Key Dates

Start Date

December 18, 2025

Primary Completion Date

November 14, 2028

Completion Date

February 24, 2029

Last Updated

March 11, 2026

Enrollment

332

ESTIMATED participants

Conditions

Myocardial Infarction

Interventions

Ziltivekimab

DRUG

Ziltivekimab Placebo

DRUG

Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

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Myocardial Infarction, AcuteMyocardial Infarction With Nonobstructive Coronary Arteries+1 more

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RECRUITINGNA

Fast Discharge After Acute Myocardial Infarction Discharge MI

NCT06744322

Acute Myocardial Infarction (AMI)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

Fast Discharge After Acute Myocardial Infarction Discharge MI

Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone

SuperSaturated Oxygen Comprehensive Observational Registry

Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction