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

Kobe University24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease Thin-cap fIbroatheroma

Interventions

AlirocumabDRUG

the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, Japan

RECRUITING

Outcomes

Primary Outcomes

the change in fibrous cap thickness

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

Time frame: 9 month

Secondary Outcomes

the change in fibrous cap thickness

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

Time frame: 9 month

the change in lipid index

absolute change in lipid index between baseline and 36-week follow-up

Time frame: 9 month

the change in lipid index

percentage change in lipid index between baseline and 36-week follow-up

Time frame: 9 month

the change in lipid length,

absolute change in lipid core length between baseline and 36-week follow-up

Time frame: 9 month

the change in lipid length,

percentage change in lipid core length between baseline and 36-week follow-up

Time frame: 9 month

the change in mean lipid arc

absolute change in mean lipid arc between baseline and 36-week follow-up

Time frame: 9 month

the change in mean lipid arc

percentage change in mean lipid arc between baseline and 36-week follow-up

Time frame: 9 month

Central Contacts

Hiromasa Otake, M.D, Ph,D

CONTACT

+81-78-382-5846 hotake@med.kobe-u.ac.jp

Data from ClinicalTrials.gov

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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

Time frame: 9 month

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

Time frame: 9 month

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

Time frame: 9 month

the change in minimum lumen area

absolute change in minimum lumen area between baseline and 36-week follow-up

Time frame: 9 month

the change in minimum lumen area

percentage of change in minimum lumen area between baseline and 36-week follow-up

Time frame: 9 month

the number of thin-cap fibroatheroma

change of the number of thin-cap fibroatheroma at 36-week follow-up

Time frame: 9 month

the change in total cholesterol

absolute change in serum level of of total cholesterol between baseline and 36-week follow-up

Time frame: 9 month

the change in total cholesterol

percent change in serum level of of total cholesterol between baseline and 36-week follow-up

Time frame: 9 month

the change in LDL-C

absolute change in serum level of of LDL-C between baseline and 36-week follow-up

Time frame: 9 month

the change in LDL-C

percentage change in serum level of of LDL-C between baseline and 36-week follow-up

Time frame: 9 month

the change in HDL-C

absolute change in serum level of of HDL-C between baseline and 36-week follow-up

Time frame: 9 month

the change in HDL-C

percentage change in serum level of of HDL-C between baseline and 36-week follow-up

Time frame: 9 month

the change in non-HDL-C

absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up

Time frame: 9 month

the change in non-HDL-C

percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up

Time frame: 9 month

the change in apolipoprotein B

absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up

Time frame: 9 month

the change in apolipoprotein B

percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up

Time frame: 9 month

the change in Lp(a)

absolute change in serum level of of Lp (a) between baseline and 36-week follow-up

Time frame: 9 month

the change in Lp(a)

percentage change in serum level of of Lp (a) between baseline and 36-week follow-up

Time frame: 9 month

the change in hs-CRP

absolute change in serum level of hs-CRP between baseline and 36-week follow-up

Time frame: 9 month

the change in hs-CRP

percentage change in serum level of hs-CRP between baseline and 36-week follow-up

Time frame: 9 month

the change in IL-1β

absolute change in serum level of IL-1β between baseline and 36-week follow-up

Time frame: 9 month

the change in IL-1β

percentage change in serum level of IL-1β between baseline and 36-week follow-up

Time frame: 9 month

the change in IL-6

absolute change in serum level of IL-6 between baseline and 36-week follow-up

Time frame: 9 month

the change in IL-6

percentage change in serum level of IL-6 between baseline and 36-week follow-up

Time frame: 9 month

the change in TNF-α

absolute change in serum level of TNF-α between baseline and 36-week follow-up

Time frame: 9 month

the change in TNF-α

percentage change in serum level of TNF-α between baseline and 36-week follow-up

Time frame: 9 month

the change in MCP-1

absolute change in serum level of MCP-1 between baseline and 36-week follow-up

Time frame: 9 month

the change in MCP-1

percentage change in serum level of MCP-1 between baseline and 36-week follow-up

Time frame: 9 month

the change in MMP-2

absolute change in serum level ofMMP-2 between baseline and 36-week follow-up

Time frame: 9 month

the change in MMP-2

percentage change in serum level ofMMP-2 between baseline and 36-week follow-up

Time frame: 9 month

the change in MMP-9

absolute change in serum level of MMP-9 between baseline and 36-week follow-up

Time frame: 9 month

the change in MMP-9

percentage change in serum level of MMP-9 between baseline and 36-week follow-up

Time frame: 9 month

the change in VCAM-1

absolute change in serum level of VCAM-1between baseline and 36-week follow-up

Time frame: 9 month

the change in VCAM-1

percentage change in serum level of VCAM-1 between baseline and 36-week follow-up

Time frame: 9 month

the change in ICAM-1

absolute change in serum level of ICAM-1 between baseline and 36-week follow-up

Time frame: 9 month

the change in ICAM-1

percentage change in serum level of ICAM-1 between baseline and 36-week follow-up

Time frame: 9 month

the change in free PCSK9

absolute change in serum level of free PCSK9 between baseline and 36-week follow-up

Time frame: 9 month

the change in free PCSK9

percentage change in serum level of free PCSK9 between baseline and 36-week follow-up

Time frame: 9 month