Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Proportion of high PVAT attenuation coefficient among non-target lesion(s)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mepolizumab low dose group (Drug)
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.
干预措施: Mepolizumab middle dose group (Drug)
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.
干预措施: Mepolizumab high dose group (Drug)
Placebo group
Saline, 100 ml, intravenous infusion
干预措施: Saline (Drug)
结局指标
主要结局
Proportion of high PVAT attenuation coefficient among non-target lesion(s)
时间窗: 6 months
Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA
次要结局
- 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)
- All-cause death(1 month and 6 months)
- 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)
- Device-oriented clinical endpoint (DoCE)(1 month and 6 months)
- Cardiac death(1 month and 6 months)
- Target vessel infarction(1 month and 6 months)
- Patient-oriented composite endpoint (PoCE)(1 month and 6 months)
- Any stroke(1 month and 6 months)
- Any myocardial infarction(1 month and 6 months)
- Any revascularization(1 month and 6 months)
- Changes in gene expression of peripheral blood mononuclear cells(6 months)
- Any adverse events(1, 2, 3, 4, 5, and 6 months)
研究者
Ling Tao, MD, PhD
Director of the Department of Cardiology
Xijing Hospital