Clinical trial NCT06572267: Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
Official title: Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Meplazumab
coronary artery disease
inflammation
lipid deposition
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Proportion of high PVAT attenuation coefficient among non-target lesion(s)
timeFrame: 6 months
Secondary outcomes:
measure: Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up
timeFrame: 6 months
measure: Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up
timeFrame: 6 months
measure: Changes in inflammatory biomarkers from baseline to follow-up
timeFrame: 6 months
measure: Device-oriented clinical endpoint (DoCE)
timeFrame: 1 month and 6 months
measure: Cardiac death
timeFrame: 1 month and 6 months
measure: Target vessel infarction
timeFrame: 1 month and 6 months
measure: Clinically driven target lesion revascularization
timeFrame: 1 month and 6 months
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 1 month and 6 months
measure: All-cause death
timeFrame: 1 month and 6 months
measure: Any stroke
timeFrame: 1 month and 6 months
measure: Any myocardial infarction
timeFrame: 1 month and 6 months
measure: Any revascularization
timeFrame: 1 month and 6 months
measure: Changes in gene expression of peripheral blood mononuclear cells
timeFrame: 6 months
measure: Any adverse events
timeFrame: 1, 2, 3, 4, 5, and 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Ping Zhu, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.