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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)

Primary Purpose

Coronary Artery Disease, Angina Pectoris

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily
Rosuvastatin calcium10mg
Sponsored by
Kobe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Alirocumab, NIRS-IVUS, LCBI

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kobe University Graduate School of Medicine, Department of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive therapy group

Standard therapy group

Arm Description

Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily.

The standard therapy group is Rosuvastatin10mg/daily alone.

Outcomes

Primary Outcome Measures

maxLCBI (4mm)

Secondary Outcome Measures

change amount of LCBI(lesion)
change amount of Angle of lipid core
change amount of LDL-Cholesterol level

Full Information

First Posted
May 7, 2018
Last Updated
August 29, 2018
Sponsor
Kobe University
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1. Study Identification

Unique Protocol Identification Number
NCT03529253
Brief 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
Acronym
ANTARES
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kobe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina Pectoris
Keywords
Alirocumab, NIRS-IVUS, LCBI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive therapy group
Arm Type
Experimental
Arm Description
Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily.
Arm Title
Standard therapy group
Arm Type
Active Comparator
Arm Description
The standard therapy group is Rosuvastatin10mg/daily alone.
Intervention Type
Drug
Intervention Name(s)
Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily
Intervention Description
Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin calcium10mg
Intervention Description
Rosuvastatin10mg/daily by oral for 9 months.
Primary Outcome Measure Information:
Title
maxLCBI (4mm)
Time Frame
baseline and 9 months
Secondary Outcome Measure Information:
Title
change amount of LCBI(lesion)
Time Frame
baseline and 9 months
Title
change amount of Angle of lipid core
Time Frame
baseline and 9 months
Title
change amount of LDL-Cholesterol level
Time Frame
baseline and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiromasa Otake, MD, PhD
Phone
078-382-5846
Email
hotake@med.kobe-u.ac.jp
Facility Information:
Facility Name
Kobe University Graduate School of Medicine, Department of Cardiology
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiromasa Otake, MD
Phone
+81783825846
Email
hotake@med.kobe-u.ac.jp

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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