💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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).
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