The study is testing the effect of ziltivekimab on reducing plaque in the blood vessels of the heart, specifically aiming to manage or reduce atherosclerotic plaque. The purpose of the study is to determine whether ziltivekimab can effectively reduce this plaque. Participants will either receive ziltivekimab (the active medicine) or a placebo (a dummy medicine with no effect on the body), with the treatment assignment decided by chance. It is important to note that ziltivekimab is not yet approved in any country or region worldwide; therefore, it is a new medicine that doctors cannot prescribe. The study will last for about 15 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
332
Participants will receive ziltivekimab subcutaneously.
Participants will receive placebo matched to ziltivekimab subcutaneously.
Medizinische Universität Wien
Vienna, Austria
NOT_YET_RECRUITINGAalborg Universitetshospital Hjertemedicinsk Afdeling
Gistrup, Denmark
NOT_YET_RECRUITINGRigshospitalet - Kardiologisk Forskningsenhed
København Ø, Denmark
NOT_YET_RECRUITINGAzienda Ospedaliera San Giovanni Addolorata
Rome, Lazio, Italy
NOT_YET_RECRUITINGAzienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, Italy
NOT_YET_RECRUITINGDAI Scienze Mediche - UOC Endocrinologia
Messina, Sicily, Italy
NOT_YET_RECRUITINGPresidio Ospedaliero di Rivoli
Rivoli, To, Italy
NOT_YET_RECRUITINGOspedale Policlinico San Martino
Genova, Italy
NOT_YET_RECRUITINGAOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia
Novara, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche
Orbassano, Italy
NOT_YET_RECRUITING...and 10 more locations
Change in percent atheroma volume (PAV) as determined by greyscale intravascular ultrasound (IVUS) in matched regions of interest
Percentage (%).
Time frame: From randomisation (week 0) to end-of-study (52-week)
Change in maximum lipid core burden index (LCBI) in any 4-mm segment(maxLCBI4mm) as determined by Near-infrared spectroscopy (NIRS) in matched regions of interest
Lipid core burden index (LCBI) (0 to 1000).
Time frame: From randomisation (week 0) to end-of-study (52-week)
Change in minimal fibrous cap thickness as determined by (optical coherence tomography) OCT in matched regions of interest
Micro meter (µmeter).
Time frame: From randomisation (week 0) to end-of-study (52-week)
Change in lipid core burden index (LCBI) total as determined by NIRS in matched regions of interest
LCBI index (0 to 1000).
Time frame: From randomisation (week 0) to end-of-study (52-week)
Change in average angular extension (AAE) of macrophages as determined by OCT in matched regions of interest
Degrees (°).
Time frame: From randomisation (week 0) to end-of-study (52-week)
Change in normalized total atheroma volume (NTAV) by IVUS in matched regions of interest
Cubic Millimeter (mm3).
Time frame: From randomisation (week 0) to end-of-study (52-week)
Change in mean fibrous cap thickness as determined by OCT in matched region of interest
µmeter.
Time frame: From randomisation (week 0) to end-of-study (52-week)
Change in interleukin6 (IL-6)
Picograms per milliliter (pg/mL).
Time frame: From randomisation (week 0) to week 4, and week 52
Change in high-sensitivity C-reactive protein (hs-CRP)
Milligrams per deciliter (mg/dL).
Time frame: From randomisation (week 0) to week 4, and week 52
Change in high-sensitivity Troponin T (hs-TnT)
Nanograms per milliliter (ng/mL).
Time frame: From randomisation (week 0) to week 4, and week 52
Change in N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)
Picograms per milliliter (pg/mL).
Time frame: From randomisation (week 0) to week 4, and week 52
Change in lipid and inflammatory markers
Time frame: From randomisation (week 0) to week 4, and week 52
Time to first occurrence of: All-cause death
Number of first occurrences and time-to-event.
Time frame: From randomisation (week 0) to end-of-study (52 weeks)
Time to first occurrence of: Cardiac death
Number of first occurrences and time-to-event.
Time frame: From randomisation (week 0) to end-of-study (52-week)
Time to first occurrence of:Non-fatal spontaneous myocardial infarction
Number of first occurrences and time-to-event.
Time frame: From randomisation (week 0) to end-of-study (52-week)
Time to first occurrence of: Any coronary revascularization
Number of first occurrences and time-to-event.
Time frame: From randomisation (week 0) to end-of-study (52-week)
Time to first occurrence of: Non-fatal stroke
Number of first occurrences and time-to-event.
Time frame: From randomisation (week 0) to end-of-study (52-week)
Time to first occurrence of:Transient ischemic attack
Number of first occurrences and time-to-event.
Time frame: From randomisation (week 0) to end-of-study (52-week)
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