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Recruiting NCT06572267

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

Phase II Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mepolizumab low dose group, Mepolizumab middle dose group, Mepolizumab high dose group, Saline.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Proportion of high PVAT attenuation coefficient among non-target lesion(s) [Time frame: 6 months]
Secondary outcome measures (12)
  • Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up [Time frame: 6 months]
  • Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up [Time frame: 6 months]
  • Changes in inflammatory biomarkers from baseline to follow-up [Time frame: 6 months]
  • Device-oriented clinical endpoint (DoCE) [Time frame: 1 month and 6 months]
  • Cardiac death [Time frame: 1 month and 6 months]
  • Target vessel infarction [Time frame: 1 month and 6 months]
  • Clinically driven target lesion revascularization [Time frame: 1 month and 6 months]
  • Patient-oriented composite endpoint (PoCE) [Time frame: 1 month and 6 months]
  • All-cause death [Time frame: 1 month and 6 months]
  • Any stroke [Time frame: 1 month and 6 months]
  • Any myocardial infarction [Time frame: 1 month and 6 months]
  • Any revascularization [Time frame: 1 month and 6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Ling Tao — Xi'an

Publications

  • 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

Identifiers

NCT: NCT06572267 · KY20242170-F-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗