Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome

Sponsor
Korea University Anam Hospital
Study ID
NCT04719221
Phase
PHASE4
Status
Unknown

Conditions

  • Acute Coronary Syndrome
  • Clinical Trial

Eligibility Criteria

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

Interventions

  • Evolocumab — DRUG
    The maximum dose of combined cholesterol therapy (Statin + Ezetimibe) is prescribed for 2 months, and a cholesterol test is performed in an outpatient clinic to ensure that LDL-Cholesterol \<70mg/dL is met. Patients who do not meet the criteria are randomized to maintain current treatment or receive additional Evolocumab according to randomization.
  • NIRS IVUS — DEVICE
    near-infrared spectroscopy

Study Details

This study aimed to investigate the impact of intensive cholesterol-lowering therapy (including evolocumab), drug treatment for high-risk plaques (Vulnerable plaques) with a high probability of developing acute coronary syndrome. The purpose of this study is to determine the effect of the change in the Lipid core burden index and compare the rate of cardiac events over 12 months following cholesterol therapy.

Key Dates

Start date
Mar 1, 2021
Status verified
Oct 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Placebo Comparator: Statin+Ezetimibe
    Drug: Statin + Ezetimibe (combined cholesterol therapy)
  • Active Comparator: Statin+Ezetimibe+Evolocumab
    Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab

Primary Outcome Measure

Change of 1-year lipid core burden index [ Time Frame: 1 year ]

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