Actively Recruiting
Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction
Led by ECRI bv · Updated on 2026-03-23
332
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
E
ECRI bv
Lead Sponsor
N
Novo Nordisk A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
Despite improvements in the treatment, coronary artery disease (CAD) remains one of the leading causes of death worldwide. Around 20% of people who have suffered a heart attack (myocardial infarction) need to be hospitalized again within a year, and 10% experience another heart attack. Despite currently available medication, patients remain at risk of further episodes after a heart attack. Scientists have discovered that inflammation in the body plays a decisive role in the development and narrowing of arterial blockages (atherosclerosis). This study aims to investigate whether a new treatment that reduces inflammation can help improve the arteries of patients with CAD. This study will examine whether blocking certain inflammation-related substances with a new medicinal product called ziltivekimab affects the buildup and composition of plaques (fatty deposits) in the coronary arteries. Special imaging diagnostic techniques will be used to look inside the arteries and check whether the treatment helps reduce the narrowing caused by dangerous plaques, which can lead to future heart attacks. This is a clinical study in which participants are randomly divided into two groups (randomization): one group will receive the new treatment ziltivekimab and other group will receive a placebo (a harmless substance with no active ingredients). Both groups will continue to receive standard treatment for heart attacks. The study lasts approximately 15 months per participant. The full scientific title of the trial is: Effects of ziltivekimab versus placebo on coronary atherosclerosis in patients with acute myocardial infarction. A study with serial multi-vessel imaging obtained using intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography techniques.
CONDITIONS
Official Title
Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent obtained before any study-related activities.
- Age 18 years or above at the time of providing informed consent.
- Diagnosis of acute myocardial infarction with at least one coronary segment treated with PCI.
- Presence of at least two major native coronary arteries suitable for intracoronary imaging immediately after PCI.
You will not qualify if you...
- Known or suspected hypersensitivity to study treatments or related products.
- Allergy to contrast medium, heparin, aspirin, ticagrelor, or prasugrel.
- Female of childbearing potential.
- Left-main coronary artery disease.
- Three-vessel coronary artery disease.
- History of coronary artery bypass surgery.
- TIMI flow less than 2 in the infarct-related artery after PCI.
- Unstable clinical status including hemodynamic or electrical instability.
- Significant coronary calcification or tortuosity preventing imaging evaluations.
- Uncontrolled cardiac arrhythmia.
- Severe kidney impairment.
- Active liver disease or hepatic dysfunction.
- Current or anticipated use of anti-IL-6 products during the study.
- Use or anticipated chronic use of systemic immunosuppressive or disease modifying anti-rheumatic drugs.
- Known or suspected active infection or major hematologic, metabolic, or endocrine dysfunction.
- History of recurrent serious infections.
- Use of preventive systemic antibiotics, antivirals, or antifungals.
- Known acute or chronic hepatitis B or C.
- Planned surgery within 12 months from screening.
- History of cancer within the past 5 years except certain treated skin and cervical cancers or low-risk prostate conditions.
- Estimated life expectancy less than 2 years.
- Receipt of live or attenuated-live vaccine within 4 weeks before intervention or planned during treatment.
- Major cardiac surgery within past 60 days or planned at randomization or as treatment for current AMI.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bern University Hospital, Inselspital Bern
Bern, Switzerland
Actively Recruiting
Research Team
A
Anita Dekker
CONTACT
E
Ernest Spitzer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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