The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics.
Eligibility
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 50 years and older.
* Multi-vessel coronary artery disease (defined as CAD-RADS ≥2).
* Serum hsCRP level ≥2 mg/L.
Exclusion Criteria:
* Coronary stents in situ.
* Chronic or recent (\<1 month) (serious) infections and/or clinical signs of acute (serious) infection.
* History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders.
* Use of preventive systemic antibiotics (antibiotics used to treat latent tuberculosis are exempted).
* Stable lipid lowering treatment for less than 4 weeks, including statins, ezetimibe and PCSK9 inhibition.
* Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus (HIV) not on stable antiretroviral regimen
* Uncontrolled diabetes (HbA1c \>90 mmol/mol).
* Renal insufficiency, defined as eGFR \<45 ml/min/1.73 m2.
* Platelet count \<120,000 and \>450,000 /mm3.
* Elevated liver enzymes (\>3 ULN of liver transaminases), acute liver failure or known (severe) liver disease.
* Premenopausal women not using birth-control.
* History of gastrointestinal perforation, active diverticulitis (within 5 years) or active inflammatory bowel disease (within 12 months).
* Uncontrolled hypertension (systolic \>180 mmHg; diastolic \>110 mmHg).
* Diagnosis of (active) malignancy in last 5 years.
* Standard contra-indications to 68Ga-DOTATATE PET, and CT based on physician's experience and current practices.
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Primary outcome measure(s)
TBRmax coronary arteries — 5.5 months mean percentage change in coronary arteries target to background ratio (TBRmax)
monocyte activation marker protein expression — 5.5 months The impact of ziltivekimab on a mass cytometry monocyte phenotype panel; expression markers such as CD14 and CD16.
Trial sites (1)
Facility
City
Region
Status
Amsterdam UMC, location AMC
Amsterdam
Netherlands
More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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