Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

Официальное название

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

Обзор

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.

Вмешательства

• Препарат Mepolizumab 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.
• Препарат Mepolizumab 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.
• Препарат Mepolizumab 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.
• Препарат Saline
  Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.

Первичные конечные точки

• Proportion of high PVAT attenuation coefficient among non-target lesion(s) [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up [Срок оценки: 6 months]
• Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up [Срок оценки: 6 months]
• Changes in inflammatory biomarkers from baseline to follow-up [Срок оценки: 6 months]
• Device-oriented clinical endpoint (DoCE) [Срок оценки: 1 month and 6 months]
• Cardiac death [Срок оценки: 1 month and 6 months]
• Target vessel infarction [Срок оценки: 1 month and 6 months]
• Clinically driven target lesion revascularization [Срок оценки: 1 month and 6 months]
• Patient-oriented composite endpoint (PoCE) [Срок оценки: 1 month and 6 months]
• All-cause death [Срок оценки: 1 month and 6 months]
• Any stroke [Срок оценки: 1 month and 6 months]
• Any myocardial infarction [Срок оценки: 1 month and 6 months]
• Any revascularization [Срок оценки: 1 month and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 \&amp;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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ling Tao — Сиань

Публикации

• 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. PMID 25824988
• 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. PMID 38166463

Идентификаторы

NCT: NCT06572267 · KY20242170-F-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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