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

Who is this study for? Patients with high-risk plaques with a high probability of developing acute coronary syndrome
What treatments are being studied? Evolocumab
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Over 19 years old

• Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information

• Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary syndrome

• Patients who did not meet the LDL-Cholesterol level (\<70mg/dL) even after receiving the maximum dose of combined cholesterol therapy for 2 months

Locations
Other Locations
Republic of Korea
Korea University Anam Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Statin+Ezetimibe
Drug: Statin + Ezetimibe (combined cholesterol therapy)
Active_comparator: Statin+Ezetimibe+Evolocumab
Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab
Sponsors
Leads: Korea University Anam Hospital

This content was sourced from clinicaltrials.gov

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