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The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography (ALTAIR)

Primary Purpose

Coronary Artery Disease, Thin-cap fIbroatheroma

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Alirocumab
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, Thin-cap fIbroatheroma (TCFA), vulnerable plaque, Optical Coherence Tomography (OCT)

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients who underwent PCI for ACS or stable coronary heart disease
  2. Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
  3. Patients who have been had TCFA detected by OCT
  4. Patients aged ≥20 years old at PCI
  5. Patients who agree to be enrolled in the trial giving signed written informed consent

Exclusion Criteria:

  1. Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
  2. Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit
  3. Known hypersensitivity to alirocumab or rosuvastatin
  4. All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
  5. Known history of hemorrhagic stroke
  6. Currently under treatment for cancer
  7. Patients on lipoprotein apheresis
  8. Patients with severe liver or renal dysfunction
  9. Pregnant or breast-feeding women
  10. Considered by the investigator as inappropriate for this study for any reason

Sites / Locations

  • Kobe University Graduate School of Medicine, Department of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alirocumab therapy group

standard statin therapy group

Arm Description

start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day

start with only rosuvastatin 10mg per day

Outcomes

Primary Outcome Measures

the change in fibrous cap thickness
the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up

Secondary Outcome Measures

the change in fibrous cap thickness
the percent change in minimum fibrous-cap thickness between baseline and 36-week follow-up
the change in lipid index
absolute change in lipid index between baseline and 36-week follow-up
the change in lipid index
percentage change in lipid index between baseline and 36-week follow-up
the change in lipid length,
absolute change in lipid core length between baseline and 36-week follow-up
the change in lipid length,
percentage change in lipid core length between baseline and 36-week follow-up
the change in mean lipid arc
absolute change in mean lipid arc between baseline and 36-week follow-up
the change in mean lipid arc
percentage change in mean lipid arc between baseline and 36-week follow-up
the change in max lipid arc
absolute change in max lipid arc between baseline and 36-week follow-up
the change in max lipid arc
percent change in max lipid arc between baseline and 36-week follow-up
the change in macrophage grade
absolute change in summation of macrophage grade between baseline and 36-week follow-up. macrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation <1 quadrant; grade 3, clustered accumulation >1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3
the change in macrophage grade
percentage change in summation of macrophage grade between baseline and 36-week follow-up. macrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation <1 quadrant; grade 3, clustered accumulation >1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3
the change in minimum lumen area
absolute change in minimum lumen area between baseline and 36-week follow-up
the change in minimum lumen area
percentage of change in minimum lumen area between baseline and 36-week follow-up
the number of thin-cap fibroatheroma
change of the number of thin-cap fibroatheroma at 36-week follow-up
the change in total cholesterol
absolute change in serum level of of total cholesterol between baseline and 36-week follow-up
the change in total cholesterol
percent change in serum level of of total cholesterol between baseline and 36-week follow-up
the change in LDL-C
absolute change in serum level of of LDL-C between baseline and 36-week follow-up
the change in LDL-C
percentage change in serum level of of LDL-C between baseline and 36-week follow-up
the change in HDL-C
absolute change in serum level of of HDL-C between baseline and 36-week follow-up
the change in HDL-C
percentage change in serum level of of HDL-C between baseline and 36-week follow-up
the change in non-HDL-C
absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up
the change in non-HDL-C
percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up
the change in apolipoprotein B
absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up
the change in apolipoprotein B
percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up
the change in Lp(a)
absolute change in serum level of of Lp (a) between baseline and 36-week follow-up
the change in Lp(a)
percentage change in serum level of of Lp (a) between baseline and 36-week follow-up
the change in hs-CRP
absolute change in serum level of hs-CRP between baseline and 36-week follow-up
the change in hs-CRP
percentage change in serum level of hs-CRP between baseline and 36-week follow-up
the change in IL-1β
absolute change in serum level of IL-1β between baseline and 36-week follow-up
the change in IL-1β
percentage change in serum level of IL-1β between baseline and 36-week follow-up
the change in IL-6
absolute change in serum level of IL-6 between baseline and 36-week follow-up
the change in IL-6
percentage change in serum level of IL-6 between baseline and 36-week follow-up
the change in TNF-α
absolute change in serum level of TNF-α between baseline and 36-week follow-up
the change in TNF-α
percentage change in serum level of TNF-α between baseline and 36-week follow-up
the change in MCP-1
absolute change in serum level of MCP-1 between baseline and 36-week follow-up
the change in MCP-1
percentage change in serum level of MCP-1 between baseline and 36-week follow-up
the change in MMP-2
absolute change in serum level ofMMP-2 between baseline and 36-week follow-up
the change in MMP-2
percentage change in serum level ofMMP-2 between baseline and 36-week follow-up
the change in MMP-9
absolute change in serum level of MMP-9 between baseline and 36-week follow-up
the change in MMP-9
percentage change in serum level of MMP-9 between baseline and 36-week follow-up
the change in VCAM-1
absolute change in serum level of VCAM-1between baseline and 36-week follow-up
the change in VCAM-1
percentage change in serum level of VCAM-1 between baseline and 36-week follow-up
the change in ICAM-1
absolute change in serum level of ICAM-1 between baseline and 36-week follow-up
the change in ICAM-1
percentage change in serum level of ICAM-1 between baseline and 36-week follow-up
the change in free PCSK9
absolute change in serum level of free PCSK9 between baseline and 36-week follow-up
the change in free PCSK9
percentage change in serum level of free PCSK9 between baseline and 36-week follow-up

Full Information

First Posted
May 7, 2018
Last Updated
November 11, 2018
Sponsor
Kobe University
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1. Study Identification

Unique Protocol Identification Number
NCT03552432
Brief Title
The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography
Acronym
ALTAIR
Official Title
The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography: Single Center, Randomized, Open-label, Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2021 (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 show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration
Detailed Description
The investigators investigate to evaluate the efficacy of alirocumab for vulnerable plaque. The investigators enrolled the patient with standard statin therapy who were detected vulnerable plaque by optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin were categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group. The investigators compare these two group for outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Thin-cap fIbroatheroma
Keywords
alirocumab, Thin-cap fIbroatheroma (TCFA), vulnerable plaque, Optical Coherence Tomography (OCT)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Alirocumab therapy group
Arm Type
Experimental
Arm Description
start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day
Arm Title
standard statin therapy group
Arm Type
No Intervention
Arm Description
start with only rosuvastatin 10mg per day
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Intervention Description
the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months
Primary Outcome Measure Information:
Title
the change in fibrous cap thickness
Description
the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up
Time Frame
9 month
Secondary Outcome Measure Information:
Title
the change in fibrous cap thickness
Description
the percent change in minimum fibrous-cap thickness between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in lipid index
Description
absolute change in lipid index between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in lipid index
Description
percentage change in lipid index between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in lipid length,
Description
absolute change in lipid core length between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in lipid length,
Description
percentage change in lipid core length between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in mean lipid arc
Description
absolute change in mean lipid arc between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in mean lipid arc
Description
percentage change in mean lipid arc between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in max lipid arc
Description
absolute change in max lipid arc between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in max lipid arc
Description
percent change in max lipid arc between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in macrophage grade
Description
absolute change in summation of macrophage grade between baseline and 36-week follow-up. macrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation <1 quadrant; grade 3, clustered accumulation >1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3
Time Frame
9 month
Title
the change in macrophage grade
Description
percentage change in summation of macrophage grade between baseline and 36-week follow-up. macrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation <1 quadrant; grade 3, clustered accumulation >1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3
Time Frame
9 month
Title
the change in minimum lumen area
Description
absolute change in minimum lumen area between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in minimum lumen area
Description
percentage of change in minimum lumen area between baseline and 36-week follow-up
Time Frame
9 month
Title
the number of thin-cap fibroatheroma
Description
change of the number of thin-cap fibroatheroma at 36-week follow-up
Time Frame
9 month
Title
the change in total cholesterol
Description
absolute change in serum level of of total cholesterol between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in total cholesterol
Description
percent change in serum level of of total cholesterol between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in LDL-C
Description
absolute change in serum level of of LDL-C between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in LDL-C
Description
percentage change in serum level of of LDL-C between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in HDL-C
Description
absolute change in serum level of of HDL-C between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in HDL-C
Description
percentage change in serum level of of HDL-C between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in non-HDL-C
Description
absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in non-HDL-C
Description
percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in apolipoprotein B
Description
absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in apolipoprotein B
Description
percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in Lp(a)
Description
absolute change in serum level of of Lp (a) between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in Lp(a)
Description
percentage change in serum level of of Lp (a) between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in hs-CRP
Description
absolute change in serum level of hs-CRP between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in hs-CRP
Description
percentage change in serum level of hs-CRP between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in IL-1β
Description
absolute change in serum level of IL-1β between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in IL-1β
Description
percentage change in serum level of IL-1β between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in IL-6
Description
absolute change in serum level of IL-6 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in IL-6
Description
percentage change in serum level of IL-6 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in TNF-α
Description
absolute change in serum level of TNF-α between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in TNF-α
Description
percentage change in serum level of TNF-α between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in MCP-1
Description
absolute change in serum level of MCP-1 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in MCP-1
Description
percentage change in serum level of MCP-1 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in MMP-2
Description
absolute change in serum level ofMMP-2 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in MMP-2
Description
percentage change in serum level ofMMP-2 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in MMP-9
Description
absolute change in serum level of MMP-9 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in MMP-9
Description
percentage change in serum level of MMP-9 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in VCAM-1
Description
absolute change in serum level of VCAM-1between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in VCAM-1
Description
percentage change in serum level of VCAM-1 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in ICAM-1
Description
absolute change in serum level of ICAM-1 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in ICAM-1
Description
percentage change in serum level of ICAM-1 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in free PCSK9
Description
absolute change in serum level of free PCSK9 between baseline and 36-week follow-up
Time Frame
9 month
Title
the change in free PCSK9
Description
percentage change in serum level of free PCSK9 between baseline and 36-week follow-up
Time Frame
9 month

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 have been had TCFA detected by OCT Patients aged ≥20 years old at PCI Patients who agree to be enrolled in the trial giving 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 breast-feeding women Considered by the investigator as inappropriate for this study for any reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiromasa Otake, M.D, Ph,D
Phone
+81-78-382-5846
Email
hotake@med.kobe-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiromasa Otake, M.D, Ph,D
Organizational Affiliation
Kobe University Graduate School of Medicine
Official's Role
Principal Investigator
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

Citations:
PubMed Identifier
30579806
Citation
Otake H, Sugizaki Y, Toba T, Nagano Y, Tsukiyama Y, Yanaka KI, Yamamoto H, Nagasawa A, Onishi H, Takeshige R, Nakano S, Matsuoka Y, Tanimura K, Kawamori H, Shinke T, Hirata KI. Efficacy of alirocumab for reducing plaque vulnerability: Study protocol for ALTAIR, a randomized controlled trial in Japanese patients with coronary artery disease receiving rosuvastatin. J Cardiol. 2019 Mar;73(3):228-232. doi: 10.1016/j.jjcc.2018.11.012. Epub 2018 Dec 19.
Results Reference
derived

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The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

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