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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-18

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Progression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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alirocumab therapy group

patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks

Alirocumab

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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Alirocumab

the administration of Alirocumab at least 75mg every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No