Clinical trial NCT03533959: To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy
Official title: Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease Progression
Keywords: in-stent neoatherosclerosis
alirocumab
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lipid index change between baseline and 9 month follow-up
timeFrame: Baseline and 9 month follow-up
Secondary outcomes:
measure: Macrophage grade change between baseline and 9 month follow-up
timeFrame: Baseline and 9 month follow-up
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine, Department of Cardiology
state: Hyogo
Study officials:
affiliation: Kobe University Graduate School of Medicine
name: Hiromasa Otake, M.D., Ph.D
role: STUDY_CHAIR
References: