Ziltivekimab to reduce coronary plaque after 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
This study will test whether the anti-inflammatory drug ziltivekimab can reduce plaque buildup and improve plaque composition in people who recently had a heart attack and were treated with PCI.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 332 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ECRI bv Industry-sponsored |
| Drugs / interventions | ziltivekimab |
| Locations | 1 site (Bern) |
| Trial ID | NCT07276282 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older who have had an acute myocardial infarction treated with PCI and who have at least two native coronary segments suitable for intracoronary imaging are ideal candidates.
Not a fit: Patients with left-main or three-vessel disease, prior coronary bypass surgery, very calcified or tortuous arteries that prevent imaging, or unstable clinical status are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, ziltivekimab could reduce arterial plaque burden and stabilize plaques, which may lower the risk of recurrent heart attacks.
How similar studies have performed: Anti-inflammatory approaches such as IL-1β inhibition and colchicine have reduced cardiovascular events in prior trials, while direct IL-6 blockade is less established clinically though early-phase studies show strong reductions in inflammatory markers.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.