近赤外分光法血管内超音波検査による、アリロクマブ（プロタンパク質変換酵素サブチリシン/ケキシン9型阻害剤）とロスバスタチンの併用、またはロスバスタチン単独投与が冠動脈疾患における脂質コアプラークに及ぼす影響

基本情報

NCT ID

NCT03529253

ステータス

不明

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

30

治験依頼者名

Kobe University

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)