Coronary Artery Disease, Thin-cap fIbroatheroma
Conditions
Keywords
alirocumab, Thin-cap fIbroatheroma (TCFA), vulnerable plaque, Optical Coherence Tomography (OCT)
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.
Interventions
DRUGAlirocumab
the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months
Sponsors
Kobe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in fibrous cap thickness | 9 month | the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the change in lipid index | 9 month | absolute change in lipid index between baseline and 36-week follow-up |
| the change in lipid length, | 9 month | absolute change in lipid core length between baseline and 36-week follow-up |
| the change in mean lipid arc | 9 month | absolute change in mean lipid arc between baseline and 36-week follow-up |
| the change in max lipid arc | 9 month | absolute change in max lipid arc between baseline and 36-week follow-up |
| the change in macrophage grade | 9 month | 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 minimum lumen area | 9 month | absolute change in minimum lumen area between baseline and 36-week follow-up |
| the number of thin-cap fibroatheroma | 9 month | change of the number of thin-cap fibroatheroma at 36-week follow-up |
| the change in total cholesterol | 9 month | absolute change in serum level of of total cholesterol between baseline and 36-week follow-up |
| the change in LDL-C | 9 month | absolute change in serum level of of LDL-C between baseline and 36-week follow-up |
| the change in HDL-C | 9 month | absolute change in serum level of of HDL-C between baseline and 36-week follow-up |
| the change in non-HDL-C | 9 month | absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up |
| the change in fibrous cap thickness | 9 month | the percent change in minimum fibrous-cap thickness between baseline and 36-week follow-up |
| the change in Lp(a) | 9 month | absolute change in serum level of of Lp (a) between baseline and 36-week follow-up |
| the change in hs-CRP | 9 month | absolute change in serum level of hs-CRP between baseline and 36-week follow-up |
| the change in IL-1β | 9 month | absolute change in serum level of IL-1β between baseline and 36-week follow-up |
| the change in IL-6 | 9 month | absolute change in serum level of IL-6 between baseline and 36-week follow-up |
| the change in free PCSK9 | 9 month | absolute change in serum level of free PCSK9 between baseline and 36-week follow-up |
| the change in TNF-α | 9 month | absolute change in serum level of TNF-α between baseline and 36-week follow-up |
| the change in MCP-1 | 9 month | absolute change in serum level of MCP-1 between baseline and 36-week follow-up |
| the change in MMP-2 | 9 month | absolute change in serum level ofMMP-2 between baseline and 36-week follow-up |
| the change in MMP-9 | 9 month | absolute change in serum level of MMP-9 between baseline and 36-week follow-up |
| the change in VCAM-1 | 9 month | absolute change in serum level of VCAM-1between baseline and 36-week follow-up |
| the change in ICAM-1 | 9 month | absolute change in serum level of ICAM-1 between baseline and 36-week follow-up |
| the change in apolipoprotein B | 9 month | absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up |
Countries
Japan
Contacts
Primary ContactHiromasa Otake, M.D, Ph,D
Outcome results
None listed