ZILTIVEKIMAB for Coronary artery disease

Inclusion criteria

• {"criterion_text":"- Age 50 years and older\n- Multi-vessel coronary artery disease (defined as CAD-RADS ≥2 and/or PAV/NCPV stage ≥2)\n- Serum hsCRP level ≥2 mg/L"}

Exclusion criteria

• {"criterion_text":"- Coronary stents in situ\n- Chronic or recent (<1 month) (serious) infections and/or clinical signs of acute (serious) infection\n- History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders\n- 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"}

Primary endpoints

• {"endpoint_text":"- Mean percentage change in coronary arteries target to background ratio (TBRmax) and monocyte activation marker protein expression between the treatment and placebo group, at the primary analysis time point of 20 weeks, compared to baseline.","definition_or_measurement_approach":"Comparison of mean percentage change in coronary artery TBRmax and monocyte activation marker protein expression between ziltivekimab-treated and placebo groups at 20 weeks versus baseline."}

Secondary endpoints

• {"endpoint_text":"- Difference in PCAT (CCTA derived) after ziltivekimab treatment\n- Correlation between changes in coronary 68Ga-DOTATATE uptake and anatomical plaque changes on CCTA.\n- Difference in 68Ga-DOTATATE SUVmax of bone marrow and spleen after treatment.\n- Difference in 68Ga-DOTATATE TBRmax of ascending aorta after treatment.\n- The impact of ziltivekimab on monocyte phenotype in transendothelial migration (TEM) capacity and transcriptome profile.\n- The mean percentage change in plasmatic proteins before and after ziltivekimab treatment.\n- The impact of ziltivekimab on inflammation in plasma cytokine and chemokine levels.","definition_or_measurement_approach":"Secondary endpoints include imaging-derived measures (PCAT from CCTA; 68Ga-DOTATATE SUVmax and TBRmax), correlative analyses between imaging and anatomical plaque changes, cellular assays of monocyte TEM capacity and transcriptomics, and plasma proteomic and cytokine/chemokine profiling comparing pre- and post-treatment."}

Netherlands

Earliest CTIS Part Ii Submission Date

12-11-2024

Latest Decision Or Authorization Date

19-11-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands