New drug aims to shrink heart plaque after attack
NCT ID NCT07301034
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new medicine called ziltivekimab can reduce fatty plaque buildup in heart arteries after a heart attack. About 332 participants will receive either the drug or a placebo for 15 months. The goal is to see if the drug helps control artery disease and prevent future heart problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 332 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 4. Study vessel must not have undergone previous PCI within the study segment. 5. A vessel which is candidate for intervention at the time of qualifying PCI or over the following 6 months in the judgment of the Investigator, cannot be a study vessel. 5\. Hemodynamic stability (as assessed by the treating physician) allowing the repetitive administration of nitroglycerine during the study specific imaging procedure. 6\. Ability to understand the requirements of the study and to provide informed consent 7. Willingness to undergo follow-up intracoronary imaging. 8. Possibility for randomisation and administration of the loading dose as early as possible after invasive procedure and latest within 48 hours after index PCI. Two study segments may be obtained in the same vessel (e.g. two study segments in the Right Coronary Artery \[RCA\] or Left Circumflex Artery \[LCX\]), at the investigators discretion, considering vessel anatomy (e.g. left or right dominance), and where suitable landmarks between segments are at least 40 mm apart and with vessel wall irregularities. 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 * Unstable clinical status (hemodynamic or electrical instability. Hemodynamic instability defined as any of the following: Killip Class III or IV. Sustained and/or symptomatic hypotension (as assessed by the treating physician). * Significant coronary calcification or tortuosity deemed to preclude Intra-Vascular Ultrasound (IVUS), Near Infrared Spectroscopy (NIRS) and Optical Coherence Tomography (OCT) evaluation. * Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 months prior to screening. * Severe kidney impairment defined as any of the following: Previous or current estimated glomerular filtration rate \<30 milliliters per minute (ml/min) /1.73 square meter (m\^2) Chronic haemodialysis or peritoneal dialysis. \- Active liver disease or hepatic dysfunction defined as at least one of the following: Previously known or current hepatic encephalopathy (clinical evaluation) Previously known or current ascites (clinical evaluation) Jaundice (clinical evaluation) Previous oesophageal/gastric variceal bleeding Known hepatitis cirrhosis * Current use of anti-interleukin (IL)-6 products or anticipated use of such drugs any time during the study. * Use of systemic immunosuppressive drugs (both small molecules and biologics) or disease modifying anti-rheumatic drugs (DMARDs including both biologic DMARDs like anti- TNFalpha and conventional DMARDs like methotrexate) or anticipated chronic use of such drugs any time during the study. (Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary. Furthermore, temporary systemic immunosuppressive treatment of e.g., chronic obstructive pulmonary disease \[COPD\] exacerbations is allowed). * Known, or suspicion of, active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator. * History of recurrent serious infections (infections leading to hospitalization or use of intravenous (i.v.) antibiotics) within the past 12 months, at the discretion of the investigator. * Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals (Note: "Systemic" is defined as oral or i.v. drugs that are absorbed into the circulation. Antibiotics used to treat latent TB are exempted). * Absolute neutrophil count \<2x10 10\^9/L * Absolute platelet count \< 120 x10\^9/L * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>8 × upper limit of normal. Participants with increased levels of ALT or AST \<=8 x upper limit of normal (ULN) are eligible at the discretion of the investigator if the investigator considers the ALT or AST elevations to be caused by the current AMI. In case the elevation is considered related to other reasons than the current AMI, participants should be excluded when ALT or AST \>2.5 x(ULN). * Known (acute or chronic) hepatitis B or hepatitis C * Planned surgery within 12 months from the time of screening. * History of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, low risk prostate cancer, or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) at the discretion of the investigator. * Estimated life expectancy less than 2 years * Presence of risk factors for tuberculosis (TB) or history or evidence of latent TB such as (but not limited to): History or evidence of a positive TB test or chest X-ray compatible with latent TB and TB treatment initiated less than 28 days prior to randomisation. * Diagnosis of human immunodeficiency virus (HIV). * History of gastrointestinal perforation (Note: History of perforated appendicitis more than 5 years old is not exclusionary). * History of active diverticulitis within the past 5 years. * History of inflammatory bowel disease that has been clinically active within the past 12 months. * History of bone marrow or solid organ transplant or anticipated to receive an organ transplant during the study. * Received a live or attenuated-live vaccine product within 4 weeks of study intervention administration or expected to receive a live or attenuated-live vaccine product during the treatment period. * Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery \[CABG\]), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG).
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
20 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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AOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia
NOT_YET_RECRUITINGNovara, 28100, Italy
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Aalborg Universitetshospital Hjertemedicinsk Afdeling
NOT_YET_RECRUITINGGistrup, 9260, Denmark
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Azienda Ospedaliera San Giovanni Addolorata
NOT_YET_RECRUITINGRome, Lazio, 00184, Italy
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Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche
NOT_YET_RECRUITINGOrbassano, 10043, Italy
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Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
NOT_YET_RECRUITINGBergamo, Lombardy, 24127, Italy
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DAI Scienze Mediche - UOC Endocrinologia
NOT_YET_RECRUITINGMessina, Sicily, 98124, Italy
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Erasmus MC
NOT_YET_RECRUITINGRotterdam, 3015 GD, Netherlands
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Fondazione Policlinico Universitario Agostino Gemelli IRCS
NOT_YET_RECRUITINGRome, 00168, Italy
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HUG-Service de Cardiologie
NOT_YET_RECRUITINGGeneva, 1205, Switzerland
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Hospital Universitario Marqués de Valdecilla
NOT_YET_RECRUITINGSantander, 39008, Spain
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Hospital Universitario de la Princesa
NOT_YET_RECRUITINGMadrid, 28006, Spain
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IRCCS Policlinico San Donato
NOT_YET_RECRUITINGSan Donato Milanese, 20097, Italy
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Inselspital-Universitätsklinik für Kardiologie
RECRUITINGBern, 3010, Switzerland
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LUKS-Herzzentrum
RECRUITINGLucerne, 6000, Switzerland
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Medizinische Universität Wien
NOT_YET_RECRUITINGVienna, 1090, Austria
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Ospedale Policlinico San Martino
NOT_YET_RECRUITINGGenova, 16132, Italy
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Presidio Ospedaliero di Rivoli
NOT_YET_RECRUITINGRivoli, To, 10098, Italy
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Radboudumc
NOT_YET_RECRUITINGNijmegen, 6525 GA, Netherlands
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Rigshospitalet - Kardiologisk Forskningsenhed
NOT_YET_RECRUITINGKøbenhavn Ø, 2100, Denmark
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Universitäres Herzzentrum
RECRUITINGBasel, 4031, Switzerland
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