NCT07276282 Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction
| NCT ID | NCT07276282 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ECRI bv |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 332 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 332 participants in total. It began in 2025-12-19 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Lorenz Räber, MD, PhD
PRINCIPAL INVESTIGATOR
Cardiology Department, Bern University Hospital, Inselspital Bern, Switzerland
Frequently Asked Questions
Who can join the NCT07276282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07276282 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 332 participants.
Is NCT07276282 currently recruiting?
Yes, NCT07276282 is actively recruiting participants. Contact the research team at adekker@cardialysis.nl for enrollment information.
Where is the NCT07276282 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07276282 clinical trial?
NCT07276282 is sponsored by ECRI bv. The principal investigator is Lorenz Räber, MD, PhD at Cardiology Department, Bern University Hospital, Inselspital Bern, Switzerland. The trial plans to enroll 332 participants.