Coronary Artery Disease
Conditions
Keywords
Meplazumab, coronary artery disease, inflammation, lipid deposition
Brief summary
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.
Interventions
DRUGMepolizumab low dose group
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.
DRUGMepolizumab middle dose group
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.
DRUGMepolizumab high dose group
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.
DRUGSaline
Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with chronic coronary syndrome 2. Non-target lesions with stenosis ≥50% by visual assessment 3. Angina symptoms manageable via antianginal medication 4. High attenuation coefficient (≥-70.1 HU) of perivascular adipose tissue (PVAT) around non-target lesions as assessed by coronary CT angiography (CCTA) 5. Patients who are able to complete the follow-up and compliant to the prescribed medication
Exclusion criteria
1. Under the age of 18 2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint 3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice) 4. Concurrent medical condition with a life expectancy of less than 3 years 5. Haemodynamical unstable 6. Known contraindications to medications such as test drug and its components, heparin, or contrast 7. The following criteria are met for any of the laboratory test indicators at the time of screening ①ALT/AST \>3ULN；②TBil ≥2ULN；③WBC\>2ULN；④NEUT\<0.5×109 /L；⑤PLT\<30×109 /L；⑥eGFR \&lt;60 mL/min/1.73 m2（CKD-EPI formula） 8. Suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of high PVAT attenuation coefficient among non-target lesion(s) | 6 months | Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gene expression of peripheral blood mononuclear cells | 6 months | — |
| Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up | 6 months | — |
| Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up | 6 months | — |
| Changes in inflammatory biomarkers from baseline to follow-up | 6 months | 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 |
| Device-oriented clinical endpoint (DoCE) | 1 month and 6 months | Device-oriented clinical endpoint is a composite endpoint including cardiac death, target vessel infarction, and clinically driven target lesion revascularization |
| Cardiac death | 1 month and 6 months | The individual component of the DoCE |
| Target vessel infarction | 1 month and 6 months | The individual component of the DoCE |
| Clinically driven target lesion revascularization | 1 month and 6 months | The individual component of the DoCE |
| Patient-oriented composite endpoint (PoCE) | 1 month and 6 months | Patient-oriented composite endpoint is a composite endpoint including all-cause death, any stroke, any myocardial infarctions, and any revascularization |
| All-cause death | 1 month and 6 months | The individual component of the PoCE |
| Any stroke | 1 month and 6 months | The individual component of the PoCE |
| Any myocardial infarction | 1 month and 6 months | The individual component of the PoCE |
| Any revascularization | 1 month and 6 months | The individual component of the PoCE |
| Any adverse events | 1, 2, 3, 4, 5, and 6 months | All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0 |
Countries
China
Contacts
CONTACTChao Gao, M.D., Ph.D.
STUDY_CHAIRLing Tao, M.D., Ph.D.
Xijing Hospital
STUDY_CHAIRPing Zhu, M.D., Ph.D.
Xijing Hospital
STUDY_CHAIRChao Gao, M.D., Ph.D.
Xijing Hospital
Outcome results
None listed