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

Sponsor
Kobe University
Study ID
NCT03533959
Status
Unknown

Conditions

  • Coronary Artery Disease Progression

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    the administration of Alirocumab at least 75mg every 2 weeks

Study Details

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.

Key Dates

Start date
Dec 18, 2017
Status verified
May 2018
Primary completion
Dec 31, 2020
Completion
Dec 31, 2025

Study Design

Enrollment
31 participants (estimated)

Arms

  • Arm: alirocumab therapy group
    patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks
  • Arm: standard statin therapy group
    patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor

Primary Outcome Measure

Lipid index change between baseline and 9 month follow-up [ Time Frame: Baseline and 9 month follow-up ]

Central Contacts