Ling Tao
Xi'an, Shannxi, 710032, China
Location status: Recruiting
NCT Number: NCT06572267
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Xi'an, Shannxi, 710032, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.
Time frame: 6 months
Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA
Time frame: 6 months
Time frame: 6 months
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
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
Time frame: 1 month and 6 months
The individual component of the DoCE
Time frame: 1 month and 6 months
The individual component of the DoCE
Time frame: 1 month and 6 months
The individual component of the DoCE
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
Time frame: 1 month and 6 months
The individual component of the PoCE
Time frame: 1 month and 6 months
The individual component of the PoCE
Time frame: 1 month and 6 months
The individual component of the PoCE
Time frame: 1 month and 6 months
The individual component of the PoCE
Time frame: 6 months
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
Contact information is provided by the study sponsor or research team.
Xijing Hospital
Other
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial
Acronym: REC-SAFECAD
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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