Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

Launched by XIJING HOSPITAL · Aug 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called mepolizumab to see how it affects patients with coronary artery disease, which is a condition where the heart's blood vessels become narrowed due to plaque buildup. The researchers want to understand if mepolizumab can help reduce inflammation and fat deposits in these blood vessels over a long period. This study is particularly focused on individuals who have chronic coronary syndrome and are experiencing manageable chest pain.

To participate, you need to be between the ages of 65 and 74, have certain types of blockages in your heart arteries, and be able to follow the study's guidelines. If you join, you will be monitored closely to ensure your safety and to see how well the medication works. It’s important to note that certain health conditions or circumstances, like being pregnant or having serious health issues, may prevent you from taking part in this trial. Overall, this study aims to find a new way to help patients with coronary artery disease feel better and improve their heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with chronic coronary syndrome
• • 2. Non-target lesions with stenosis ≥50% by visual assessment
• • 3. Angina symptoms manageable via antianginal medication
• • 4. High attenuation coefficient (≥-70.1 HU) of perivascular adipose tissue (PVAT) around non-target lesions as assessed by coronary CT angiography (CCTA)
• • 5. Patients who are able to complete the follow-up and compliant to the prescribed medication
• Exclusion Criteria:
• • 1. Under the age of 18
• • 2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
• • 3. 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)
• • 4. Concurrent medical condition with a life expectancy of less than 3 years
• • 5. Haemodynamical unstable
• • 6. Known contraindications to medications such as test drug and its components, heparin, or contrast
• • 7. 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）
• • 8. Suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate