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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepolizumab low dose group | Experimental | Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.05 mg/kg, monthly. Meperizumab 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. |
|
| Mepolizumab middle dose group | Experimental | Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.1 mg/kg, monthly. Meperizumab 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. |
|
| Mepolizumab high dose group | Experimental | Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.2 mg/kg, monthly. Meperizumab 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. |
|
| Placebo group | Placebo Comparator | Saline, 100 ml, intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab low dose group | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Gao, M.D., Ph.D. | Contact | 18629551066 | woshigaochao@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ling Tao, M.D., Ph.D. | Xijing Hospital | Study Chair |
| Ping Zhu, M.D., Ph.D. | Xijing Hospital | Study Chair |
| Chao Gao, M.D., Ph.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ling Tao | Recruiting | Xi'an | Shannxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25824988 | Background | Sturhan H, Ungern-Sternberg SN, Langer H, Gawaz M, Geisler T, May AE, Seizer P. Regulation of EMMPRIN (CD147) on monocyte subsets in patients with symptomatic coronary artery disease. Thromb Res. 2015 Jun;135(6):1160-4. doi: 10.1016/j.thromres.2015.03.022. Epub 2015 Mar 20. | |
| 38166463 | Background | Lv JJ, Wang H, Zhang C, Zhang TJ, Wei HL, Liu ZK, Ma YH, Yang Z, He Q, Wang LJ, Duan LL, Chen ZN, Bian H. CD147 Sparks Atherosclerosis by Driving M1 Phenotype and Impairing Efferocytosis. Circ Res. 2024 Jan 19;134(2):165-185. doi: 10.1161/CIRCRESAHA.123.323223. Epub 2024 Jan 3. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
| D044382 | Population Groups |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| Mepolizumab middle dose group | Drug | 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. |
|
| Mepolizumab high dose group | Drug | 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. |
|
| Saline | Drug | Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min. |
|
| 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 | 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 | 1 month and 6 months |
| Cardiac death | The individual component of the DoCE | 1 month and 6 months |
| Target vessel infarction | The individual component of the DoCE | 1 month and 6 months |
| Clinically driven target lesion revascularization | The individual component of the DoCE | 1 month and 6 months |
| 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 | 1 month and 6 months |
| All-cause death | The individual component of the PoCE | 1 month and 6 months |
| Any stroke | The individual component of the PoCE | 1 month and 6 months |
| Any myocardial infarction | The individual component of the PoCE | 1 month and 6 months |
| Any revascularization | The individual component of the PoCE | 1 month and 6 months |
| Changes in gene expression of peripheral blood mononuclear cells | 6 months |
| Any adverse events | All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0 | 1, 2, 3, 4, 5, and 6 months |
| Xijing Hospital |
| Study Chair |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |