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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive therapy group | Experimental | Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily. |
|
| Standard therapy group | Active Comparator | The standard therapy group is Rosuvastatin10mg/daily alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily | Drug | Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| maxLCBI (4mm) | baseline and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| change amount of LCBI(lesion) | baseline and 9 months | |
| change amount of Angle of lipid core | baseline and 9 months | |
| change amount of LDL-Cholesterol level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiromasa Otake, MD, PhD | Contact | 078-382-5846 | hotake@med.kobe-u.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University Graduate School of Medicine, Department of Cardiology | Recruiting | Kobe | Hyōgo | 650-0017 | Japan |
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| Rosuvastatin calcium10mg | Drug | Rosuvastatin10mg/daily by oral for 9 months. |
|
| baseline and 9 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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