NCT04719221

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

A Single-center, Randomized, Parallel-group, Open-label Pilot Study to Evaluate the 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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Clinical Trial
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Evolocumab	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.
DEVICE	NIRS IVUS	near-infrared spectroscopy

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-01-22
• Last updated: 2023-10-05

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study
• FDA-regulated device study