The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
Meperizumab (0.05 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.
Meperizumab (0.1 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.
Meperizumab (0.2 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.
Ling Tao
Xi'an, Shannxi, China
RECRUITINGProportion of high PVAT attenuation coefficient among non-target lesion(s)
Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA
Time frame: 6 months
Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up
Time frame: 6 months
Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up
Time frame: 6 months
Changes in inflammatory biomarkers from baseline to follow-up
Biomarkers including hs-CRP, IL-1, IL-2, IL-4, IL-6, INF-α, IL-8, IL-10, IL-12p70, IL-17, IL-1β, TNF-α and IFN-γ
Time frame: 6 months
Device-oriented clinical endpoint (DoCE)
Device-oriented clinical endpoint is a composite endpoint including cardiac death, target vessel infarction, and clinically driven target lesion revascularization
Time frame: 1 month and 6 months
Cardiac death
The individual component of the DoCE
Time frame: 1 month and 6 months
Target vessel infarction
The individual component of the DoCE
Time frame: 1 month and 6 months
Clinically driven target lesion revascularization
The individual component of the DoCE
Time frame: 1 month and 6 months
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Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.
Patient-oriented composite endpoint (PoCE)
Patient-oriented composite endpoint is a composite endpoint including all-cause death, any stroke, any myocardial infarctions, and any revascularization
Time frame: 1 month and 6 months
All-cause death
The individual component of the PoCE
Time frame: 1 month and 6 months
Any stroke
The individual component of the PoCE
Time frame: 1 month and 6 months
Any myocardial infarction
The individual component of the PoCE
Time frame: 1 month and 6 months
Any revascularization
The individual component of the PoCE
Time frame: 1 month and 6 months
Changes in gene expression of peripheral blood mononuclear cells
Time frame: 6 months
Any adverse events
All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0
Time frame: 1, 2, 3, 4, 5, and 6 months