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

Recruiting

• Conditions: Coronary Artery Disease Progression
• Interventions: Drug: Alirocumab

• Registration Number: NCT03533959
• Lead Sponsor: Kobe University

Brief 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.

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 Timeline

• Study Start: 2017-12-18
• Status Verified: 2018-05
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-05-23
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-05-30
• Primary Completion: 2020-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
alirocumab therapy group	Alirocumab	patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks

Primary Outcome Measures

Name	Time	Method
Lipid index change between baseline and 9 month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Macrophage grade change between baseline and 9 month follow-up	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.

Trial Locations

Locations (1)

Kobe University Graduate School of Medicine, Department of Cardiology; 🇯🇵 Kobe, Hyogo, Japan