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

NCT03533959 | Unknown DMC

• 1 other identifier: KobeU-170179
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease Progression

Keywords

in-stent neoatherosclerosis; alirocumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Macrophage grade change between baseline and 9 month follow-up

  Baseline and 9 month follow-up

Study Arms (2)

alirocumab therapy group

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

Drug: Alirocumab

standard statin therapy group

patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor

Interventions

Alirocumab DRUG

the administration of Alirocumab at least 75mg every 2 weeks

alirocumab therapy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kobe University: lead

Study Sites (1)

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

MeSH Terms

Interventions

alirocumab

Study Officials

• Hiromasa Otake, M.D., Ph.D

  Kobe University Graduate School of Medicine

  STUDY CHAIR

Central Study Contacts

Hiromasa Otake, M.D., Ph.D

CONTACT

+81-78-382-5111; hotake@med.kobe-u.ac.jp

Yoichiro Sugizaki, M.D.

CONTACT

+81-78-382-5111; you0724@med.kobe-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: December 18, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2025
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

JP (1)