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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease Progression
• Intervention / Treatment: Drug: Alirocumab

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 31

Contacts and Locations

• Study Contact: Name: Hiromasa Otake, M.D., Ph.D; Phone Number: +81-78-382-5111; Email: hotake@med.kobe-u.ac.jp
• Study Contact Backup: Name: Yoichiro Sugizaki, M.D.; Phone Number: +81-78-382-5111; Email: you0724@med.kobe-u.ac.jp

Study Locations

• Japan
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Recruiting
      • Kobe University Graduate School of Medicine, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. The age at the time of consent acquisition is 20 years old or over.
2. OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
3. lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
4. Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
5. Document consent has been obtained from the subject person to this research.

Exclusion Criteria:

1. Patients who have received treatment with PCSK 9 inhibitor in the past
2. Patients whose treatment was interrupted before follow-up catheterization during the observation period
3. Patients underwent LDL apheresis.
4. In the case that the researchers judges it as inappropriate as the object of this research.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
alirocumab therapy group; patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks	Drug: Alirocumab; the administration of Alirocumab at least 75mg every 2 weeks
standard statin therapy group; patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Baseline and 9 month follow-up

Collaborators and Investigators

• Sponsor: Kobe University
• Investigators: Study Chair: Hiromasa Otake, M.D., Ph.D, Kobe University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: alirocumab; in-stent neoatherosclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Coronary Disease; Coronary Artery Disease; Disease Progression
• Other Study ID Numbers: KobeU-170179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No