To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy

Coronary Artery Disease Progression Clinical Trial

— POLARIS  

Official title:

Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03533959
• Other study ID #: KobeU-170179
• Status: Recruiting
• Start date: December 18, 2017
• Est. completion date: December 2025

Study information

• Verified date: May 2018
• Source: Kobe University
• Contact: Hiromasa Otake, M.D., Ph.D
• Phone: +81-78-382-5111
• Email: hotake[@]med.kobe-u.ac.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Progression
• Coronary Disease
• Disease Progression
• Myocardial Ischemia

Intervention

Drug:
• Alirocumab
the administration of Alirocumab at least 75mg every 2 weeks

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine, Department of Cardiology	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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