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)

August 29, 2018 updated by: Hiromasa Otake, Kobe University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
        • Recruiting
        • Kobe University Graduate School of Medicine, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent PCI for ACS or stable coronary heart disease
  • Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
  • Patients who remained 25-75% stenosis with coronary angiography
  • Patients who obtained analyzable images and calculated maxLCBI (4 mm) with NIRS-IVUS
  • Patients aged ≥20 years old at PCI
  • Patients who agree to be enrolled in the trial give signed written informed consent

Exclusion Criteria:

  • Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
  • Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit
  • Known hypersensitivity to alirocumab or rosuvastatin
  • All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
  • Known history of hemorrhagic stroke
  • Currently under treatment for cancer
  • Patients on lipoprotein apheresis
  • Patients with severe liver or renal dysfunction
  • Pregnant or breastfeeding women
  • Patients recognized as inadequate by attending physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intensive therapy group
Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily.
Drug: Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily
Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months.
ACTIVE_COMPARATOR: Standard therapy group
The standard therapy group is Rosuvastatin10mg/daily alone.
Drug: Rosuvastatin calcium10mg
Rosuvastatin10mg/daily by oral for 9 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maxLCBI (4mm)
Time Frame: baseline and 9 months
baseline and 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change amount of LCBI(lesion)
Time Frame: baseline and 9 months
baseline and 9 months
change amount of Angle of lipid core
Time Frame: baseline and 9 months
baseline and 9 months
change amount of LDL-Cholesterol level
Time Frame: baseline and 9 months
baseline and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kobe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

September 30, 2020

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (ACTUAL)

May 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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