Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial
Xijing Hospital
18 participants
Oct 16, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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
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Interventions
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.
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.
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.
Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06572267