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

Sponsor
Kobe University
Study ID
NCT03529253
Phase
PHASE4
Status
Unknown

Conditions

  • Angina Pectoris
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 1, 2018
Status verified
Aug 2018
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intensive therapy group
    Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily.
  • Active Comparator: Standard therapy group
    The standard therapy group is Rosuvastatin10mg/daily alone.

Primary Outcome Measure

maxLCBI (4mm) [ Time Frame: baseline and 9 months ]

Central Contacts

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