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New drug aims to shrink heart plaque after attack

NCT ID NCT07301034

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 332 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    NOT_YET_RECRUITING

    Novara, 28100, Italy

  • Aalborg Universitetshospital Hjertemedicinsk Afdeling

    NOT_YET_RECRUITING

    Gistrup, 9260, Denmark

  • Azienda Ospedaliera San Giovanni Addolorata

    NOT_YET_RECRUITING

    Rome, Lazio, 00184, Italy

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

    NOT_YET_RECRUITING

    Orbassano, 10043, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, Lombardy, 24127, Italy

  • DAI Scienze Mediche - UOC Endocrinologia

    NOT_YET_RECRUITING

    Messina, Sicily, 98124, Italy

  • Erasmus MC

    NOT_YET_RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione Policlinico Universitario Agostino Gemelli IRCS

    NOT_YET_RECRUITING

    Rome, 00168, Italy

  • HUG-Service de Cardiologie

    NOT_YET_RECRUITING

    Geneva, 1205, Switzerland

  • Hospital Universitario Marqués de Valdecilla

    NOT_YET_RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario de la Princesa

    NOT_YET_RECRUITING

    Madrid, 28006, Spain

  • IRCCS Policlinico San Donato

    NOT_YET_RECRUITING

    San Donato Milanese, 20097, Italy

  • Inselspital-Universitätsklinik für Kardiologie

    RECRUITING

    Bern, 3010, Switzerland

  • LUKS-Herzzentrum

    RECRUITING

    Lucerne, 6000, Switzerland

  • Medizinische Universität Wien

    NOT_YET_RECRUITING

    Vienna, 1090, Austria

  • Ospedale Policlinico San Martino

    NOT_YET_RECRUITING

    Genova, 16132, Italy

  • Presidio Ospedaliero di Rivoli

    NOT_YET_RECRUITING

    Rivoli, To, 10098, Italy

  • Radboudumc

    NOT_YET_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Rigshospitalet - Kardiologisk Forskningsenhed

    NOT_YET_RECRUITING

    København Ø, 2100, Denmark

  • Universitäres Herzzentrum

    RECRUITING

    Basel, 4031, Switzerland

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