Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Interventions
- Registration Number
- NCT06572267
- Lead Sponsor
- Xijing Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 18
- Patients with chronic coronary syndrome
- Non-target lesions with stenosis ≥50% by visual assessment
- Angina symptoms manageable via antianginal medication
- High attenuation coefficient (≥-70.1 HU) of perivascular adipose tissue (PVAT) around non-target lesions as assessed by coronary CT angiography (CCTA)
- Patients who are able to complete the follow-up and compliant to the prescribed medication
- Under the age of 18
- Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
- 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)
- Concurrent medical condition with a life expectancy of less than 3 years
- Haemodynamical unstable
- Known contraindications to medications such as test drug and its components, heparin, or contrast
- 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）
- Suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Mepolizumab low dose group Mepolizumab low dose group 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. Placebo group Saline Saline, 100 ml, intravenous infusion Mepolizumab high dose group Mepolizumab high dose group 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. Mepolizumab middle dose group Mepolizumab middle dose group 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up 6 months Clinically driven target lesion revascularization 1 month and 6 months The individual component of the DoCE
All-cause death 1 month and 6 months The individual component of the PoCE
Change in PVAT attenuation coefficient of non-target lesion(s) 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
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
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
Changes in gene expression of peripheral blood mononuclear cells 6 months 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
Trial Locations
- Locations (1)
Ling Tao
🇨🇳Xi'an, Shannxi, China