Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease (REC-SAFECAD)

Air Force Military Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: Mepolizumab middle dose group; Drug: Mepolizumab high dose group; Drug: Mepolizumab low dose group; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06572267

KY20242170-F-1

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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18 participants in 4 patient groups, including a placebo group

Mepolizumab low dose group

Experimental group

Description:

Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.05 mg/kg, monthly. Meperizumab 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.

Treatment:

Drug: Mepolizumab low dose group

Mepolizumab middle dose group

Experimental group

Description:

Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.1 mg/kg, monthly. Meperizumab 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.

Treatment:

Drug: Mepolizumab middle dose group

Mepolizumab high dose group

Experimental group

Description:

Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.2 mg/kg, monthly. Meperizumab 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.

Treatment:

Drug: Mepolizumab high dose group

Placebo group

Placebo Comparator group

Description:

Saline, 100 ml, intravenous infusion

Treatment:

Drug: Saline