Evaluating Meplazumab for Patients with Coronary Artery Disease
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial
This study is testing if a new medication called mepolizumab can safely help people with high-risk coronary artery disease by reducing inflammation and fat buildup in their arteries.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | mepolizumab |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT06572267 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of mepolizumab, a humanized anti-CD147 antibody, in patients with high-risk coronary artery disease. It focuses on the long-term effects of mepolizumab on lipid deposition and inflammation in coronary atherosclerotic plaques. Participants will be assigned to different dosage groups of mepolizumab or a saline control to assess the drug's impact on their condition. The study aims to determine the optimal dosage and overall safety profile of mepolizumab in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic coronary syndrome and significant non-target lesions who can manage their angina symptoms with medication.
Not a fit: Patients under 18, those with life-threatening concurrent conditions, or women who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce inflammation and lipid buildup in coronary arteries, improving outcomes for patients with coronary artery disease.
How similar studies have performed: While the specific approach of using mepolizumab in this context is novel, similar studies targeting inflammation in coronary artery disease have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 \&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
Where this trial is running
Xi'an, Shannxi
- Ling Tao — Xi'an, Shannxi, China (Recruiting)
Study contacts
- Study coordinator: Chao Gao, M.D., Ph.D.
- Email: woshigaochao@gmail.com
- Phone: 18629551066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.