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The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.
The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group.
The investigators compare these two group for outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alirocumab therapy group | patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks |
| |
| standard statin therapy group | patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab | Drug | the administration of Alirocumab at least 75mg every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipid index change between baseline and 9 month follow-up | Lipid core arc was measured by every 0.2-mm interval throughout segments with neoatherosclerosis (NA) on optical coherence tomography (OCT) findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length. | Baseline and 9 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Macrophage grade change between baseline and 9 month follow-up | Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (<30°); grade 2, clus¬tered accumulation ≥30° and <90°; grade 3, clus¬tered accumulation ≥90° and <270°; and grade 4, clustered accumulation ≥270° and <360° . Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stent implantation who were performed coronary angiography and optical coherence tomography (OCT) follow-up of the coronary arteries were candidate.
These patients were implanted drug elutingstent including sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiromasa Otake, M.D., Ph.D | Contact | +81-78-382-5111 | hotake@med.kobe-u.ac.jp | |
| Yoichiro Sugizaki, M.D. | Contact | +81-78-382-5111 | you0724@med.kobe-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hiromasa Otake, M.D., Ph.D | Kobe University Graduate School of Medicine | Study Chair |
| 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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| ID | Term |
|---|---|
| C571059 | alirocumab |
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| Baseline and 9 month follow-up |