To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy (POLARIS)
Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Hiromasa Otake, M.D., Ph.D
- Numero di telefono: +81-78-382-5111
- Email: hotake@med.kobe-u.ac.jp
Backup dei contatti dello studio
- Nome: Yoichiro Sugizaki, M.D.
- Numero di telefono: +81-78-382-5111
- Email: you0724@med.kobe-u.ac.jp
Luoghi di studio
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Hyogo
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Kobe, Hyogo, Giappone, 650-0017
- Reclutamento
- Kobe University Graduate School of Medicine, Department of Cardiology
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
Inclusion Criteria:
- The age at the time of consent acquisition is 20 years old or over.
- OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
- lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
- Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
- Document consent has been obtained from the subject person to this research.
Exclusion Criteria:
- Patients who have received treatment with PCSK 9 inhibitor in the past
- Patients whose treatment was interrupted before follow-up catheterization during the observation period
- Patients underwent LDL apheresis.
- In the case that the researchers judges it as inappropriate as the object of this research.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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alirocumab therapy group
patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks
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the administration of Alirocumab at least 75mg every 2 weeks
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standard statin therapy group
patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Lipid index change between baseline and 9 month follow-up
Lasso di tempo: Baseline and 9 month follow-up
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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.
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Baseline and 9 month follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Macrophage grade change between baseline and 9 month follow-up
Lasso di tempo: Baseline and 9 month follow-up
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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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Baseline and 9 month follow-up
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Hiromasa Otake, M.D., Ph.D, Kobe University Graduate School of Medicine
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KobeU-170179
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