Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

Last updated: October 29, 2024
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Coronary Artery Disease

Chest Pain

Thrombosis

Treatment

Mepolizumab high dose group

Saline

Mepolizumab middle dose group

Clinical Study ID

NCT06572267
KY20242170-F-1
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 prescribedmedication

Exclusion

Exclusion Criteria:

  1. Under the age of 18

  2. Unable to give informed consent or currently participating in another trial and notyet at its primary endpoint

  3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performedwithin 7 days prior to the index procedure in women of child-bearing potentialaccording 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 timeof 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 participationin this study inappropriate

Study Design

Total Participants: 18
Treatment Group(s): 4
Primary Treatment: Mepolizumab high dose group
Phase: 2
Study Start date:
October 16, 2024
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • Ling Tao

    Xi'an, Shannxi 710032
    China

    Active - Recruiting

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