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Active Not Recruiting
NCT06263244
Specifying the Anti-inflammatory Effects of Ziltivekimab
Conditions: Atherosclerosis, Inflammation
Sex: All
Ages: 50 Years – 85 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 40
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location: Amsterdam UMC, location AMC Amsterdam
Summary
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 Criteria
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 (\90 mmol/mol).
* Renal insufficiency, defined as eGFR \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.
Source: ClinicalTrials.gov (NCT06263244). StuddyBuddy aggregates publicly available trial information.