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Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound — ANTARES  

Coronary Artery Disease Clinical Trial

Official title:
Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound

Clinical Trial Summary

The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.

Clinical Trial Description

The investigators investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS at the time of PCI and at the treatment evaluation after 9 months compared with the group of Alirocumab(Alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). And also the investigators evaluate LCBI(lesion), Angle of a lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length by NIRS-IVUS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03529253
Study type Interventional
Source Kobe University
Contact Hiromasa Otake, MD, PhD
Phone 078-382-5846
Email hotake@med.kobe-u.ac.jp
Status Recruiting
Phase Phase 4
Start date April 1, 2018
Completion date September 30, 2020
View Details
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