The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

Sponsor
Kobe University
Study ID
NCT03552432
Phase
PHASE4
Status
Unknown

Conditions

  • Coronary Artery Disease
  • Thin-cap fIbroatheroma

Eligibility Criteria

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

Interventions

  • Alirocumab — DRUG
    the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months

Study Details

the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration

Key Dates

Start date
Aug 23, 2017
Status verified
Nov 2018
Primary completion
Sep 30, 2020
Completion
Sep 30, 2021

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab therapy group
    start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day
  • No Intervention: standard statin therapy group
    start with only rosuvastatin 10mg per day

Primary Outcome Measure

the change in fibrous cap thickness [ Time Frame: 9 month ]

Central Contacts

Related Studies