Status:
RECRUITING
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
Lead Sponsor:
Xijing Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06572267
Start Date
October 16 2024
End Date
March 1 2026
Last Update
November 1 2024
Active Locations (1)
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1
Ling Tao
Xi'an, Shannxi, China, 710032