Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT06572267
- Lead Sponsor
- Xijing Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria:<br><br> 1. Patients with chronic coronary syndrome treated with second-generation drug-eluting<br> stent<br><br> 2. Non-target lesions with stenosis =50% by visual assessment<br><br> 3. Angina symptoms manageable via antianginal medication<br><br> 4. Baseline high-sensitivity C-reactive protein (hs-CRP) =2 mg/L<br><br> 5. High attenuation coefficient (=-70.1 HU) of perivascular adipose tissue (PVAT)<br> around non-target lesions as assessed by coronary CT angiography (CCTA)<br><br> 6. Patients who are able to complete the follow-up and compliant to the prescribed<br> medication<br><br>Exclusion Criteria:<br><br> 1. Under the age of 18<br><br> 2. Unable to give informed consent or currently participating in another trial and not<br> yet at its primary endpoint<br><br> 3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed<br> within 7 days prior to the index procedure in women of child-bearing potential<br> according to local practice)<br><br> 4. Concurrent medical condition with a life expectancy of less than 3 years<br><br> 5. Haemodynamical unstable<br><br> 6. Known contraindications to medications such as test drug and its components,<br> heparin, or contrast<br><br> 7. The following criteria are met for any of the laboratory test indicators at the time<br> of screening ?ALT/AST >3ULN;?TBil =2ULN;?WBC>2ULN;?NEUT<0.5×109 /L;?PLT<30×109<br> /L;?eGFR <60 mL/min/1.73 m2(CKD-EPI formula)<br><br> 8. Suffering from severe systemic diseases, tumors, immune system disorders,<br> infections, malignancy, which in the opinion of the investigator make participation<br> in this study inappropriate
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of high PVAT attenuation coefficient among non-target lesion(s)
- Secondary Outcome Measures
Name Time Method Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up;Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up;Changes in inflammatory biomarkers from baseline to follow-up;Device-oriented clinical endpoint (DoCE);Cardiac death;Target vessel infarction;Clinically driven target lesion revascularization;Patient-oriented composite endpoint (PoCE);All-cause death;Any stroke;Any myocardial infarction;Any revascularization;Changes in gene expression of peripheral blood mononuclear cells;Any adverse events