Ziltivekimab to reduce coronary plaque after a heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized trial gives people who recently had an acute myocardial infarction either ziltivekimab or placebo on top of standard care and uses advanced intracoronary imaging to look directly at plaque burden and composition. Imaging methods such as intravascular ultrasound (IVUS), near-infrared spectroscopy (NIRS), and optical coherence tomography (OCT) are used to measure changes in treated and non-culprit coronary segments. Participants must have had PCI for the culprit lesion and at least two other native coronary segments suitable for imaging immediately after the qualifying procedure. The study aims to link changes in plaque biology with IL-6 pathway inhibition over the study period to see if reducing inflammation favors plaque stabilization.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Informed consent obtained before any study-related activities.
* 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 PCI.
* At least two major native coronary arteries each meeting angiographic criteria for intracoronary imaging immediately following the qualifying PCI procedure.

Key Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel.
* Female of childbearing potential.
* Left-main disease.
* Three-vessel disease.
* History of coronary artery bypass surgery.
* TIMI flow \<2 of the infarct-related artery after PCI.
* Unstable clinical status (hemodynamic or electrical instability.
* Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation.
* Uncontrolled cardiac arrhythmia.
* Severe kidney impairment.
* Active liver disease or hepatic dysfunction.
* Current use of anti-IL-6 products or anticipated use of such drugs any time during the study.
* Use of systemic immunosuppressive drugs or disease modifying anti-rheumatic drugs or anticipated chronic use of such drugs any time during the study.
* Known, or suspicion of, active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator
* History of recurrent serious infections.
* Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals.
* 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
* 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 within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG).

Where it's running

• Bern University Hospital, Inselspital Bern
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Lorenz Räber, MD, PhD — Cardiology Department, Bern University Hospital, Inselspital Bern, Switzerland
• Study coordinator: Anita Dekker
• Email: adekker@cardialysis.nl
• Phone: 31102062828

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.