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NCT Number: NCT06572267

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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 &amp;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

Treatment and study plan

Mepolizumab low dose group

Drug

Meperizumab (0.05 mg/kg) 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.

Mepolizumab middle dose group

Drug

Meperizumab (0.1 mg/kg) 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.

Mepolizumab high dose group

Drug

Meperizumab (0.2 mg/kg) 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.

Saline

Drug

Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.

Primary outcomes

  1. Proportion of high PVAT attenuation coefficient among non-target lesion(s)

    Time frame: 6 months

    Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA

Secondary outcomes

  1. Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up

    Time frame: 6 months

  2. Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up

    Time frame: 6 months

  3. Changes in inflammatory biomarkers from baseline to follow-up

    Time frame: 6 months

    Biomarkers including hs-CRP, IL-1, IL-2, IL-4, IL-6, INF-α, IL-8, IL-10, IL-12p70, IL-17, IL-1β, TNF-α and IFN-γ

  4. Device-oriented clinical endpoint (DoCE)

    Time frame: 1 month and 6 months

    Device-oriented clinical endpoint is a composite endpoint including cardiac death, target vessel infarction, and clinically driven target lesion revascularization

  5. Cardiac death

    Time frame: 1 month and 6 months

    The individual component of the DoCE

  6. Target vessel infarction

    Time frame: 1 month and 6 months

    The individual component of the DoCE

  7. Clinically driven target lesion revascularization

    Time frame: 1 month and 6 months

    The individual component of the DoCE

  8. Patient-oriented composite endpoint (PoCE)

    Time frame: 1 month and 6 months

    Patient-oriented composite endpoint is a composite endpoint including all-cause death, any stroke, any myocardial infarctions, and any revascularization

  9. All-cause death

    Time frame: 1 month and 6 months

    The individual component of the PoCE

  10. Any stroke

    Time frame: 1 month and 6 months

    The individual component of the PoCE

  11. Any myocardial infarction

    Time frame: 1 month and 6 months

    The individual component of the PoCE

  12. Any revascularization

    Time frame: 1 month and 6 months

    The individual component of the PoCE

  13. Changes in gene expression of peripheral blood mononuclear cells

    Time frame: 6 months

  14. Any adverse events

    Time frame: 1, 2, 3, 4, 5, and 6 months

    All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Gao, M.D., Ph.D.

CONTACT

[email protected]

18629551066

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

Acronym: REC-SAFECAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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