The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography
- Registration Number
- NCT03552432
- Lead Sponsor
- Kobe University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alirocumab therapy group Alirocumab start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day
- Primary Outcome Measures
Name Time Method the change in fibrous cap thickness 9 month the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up
- Secondary Outcome Measures
Name Time Method the change in Lp(a) 9 month percentage change in serum level of of Lp (a) between baseline and 36-week follow-up
the change in TNF-α 9 month percentage change in serum level of TNF-α between baseline and 36-week follow-up
the change in MCP-1 9 month percentage change in serum level of MCP-1 between baseline and 36-week follow-up
the change in MMP-2 9 month percentage change in serum level ofMMP-2 between baseline and 36-week follow-up
the change in ICAM-1 9 month percentage change in serum level of ICAM-1 between baseline and 36-week follow-up
the change in apolipoprotein B 9 month percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up
the change in HDL-C 9 month percentage change in serum level of of HDL-C between baseline and 36-week follow-up
the change in macrophage grade 9 month 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 ≧3the change in minimum lumen area 9 month percentage of change in minimum lumen area between baseline and 36-week follow-up
the change in LDL-C 9 month percentage change in serum level of of LDL-C between baseline and 36-week follow-up
the change in total cholesterol 9 month percent change in serum level of of total cholesterol between baseline and 36-week follow-up
the change in hs-CRP 9 month percentage change in serum level of hs-CRP between baseline and 36-week follow-up
the change in IL-6 9 month percentage change in serum level of IL-6 between baseline and 36-week follow-up
the change in free PCSK9 9 month percentage change in serum level of free PCSK9 between baseline and 36-week follow-up
the change in lipid index 9 month percentage change in lipid index between baseline and 36-week follow-up
the change in lipid length, 9 month percentage change in lipid core length between baseline and 36-week follow-up
the change in mean lipid arc 9 month percentage change in mean lipid arc 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 IL-1β 9 month percentage change in serum level of IL-1β 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 max lipid arc 9 month percent change in max lipid arc between baseline and 36-week follow-up
the change in non-HDL-C 9 month percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up
the change in MMP-9 9 month percentage change in serum level of MMP-9 between baseline and 36-week follow-up
the change in VCAM-1 9 month percentage change in serum level of VCAM-1 between baseline and 36-week follow-up
Trial Locations
- Locations (1)
Kobe University Graduate School of Medicine, Department of Cardiology
🇯🇵Kobe, Hyogo, Japan