Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03529253
Status:
UNKNOWN
Last Update Posted:
2018-08-31
First Post:
2018-05-07
Brief Title:
Effect of AlirocumabProprotein Convertase SubtilisinKexin type9 Inhibitor and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound
Sponsor:
Kobe University
Organization:
Kobe University
Study Overview
Official Title:
Effect of AlirocumabProprotein Convertase SubtilisinKexin type9 Inhibitor and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANTARES
Brief 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
Detailed 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 AlirocumabAlirocumab75mg2weeklosuvastatin10mgdaily and standard treatment losuvastatin10mgdaily alone And also the investigators evaluate LCBIlesion Angle of a lipid core EEM CSA Lumen CSA Minimum lumen diameter Plaque burden Lesion length by NIRS-IVUS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None