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Clinical Trials in South Korea / NCT05782777
Recruiting Not applicable

Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial

NCT05782777 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2023-04-07
Last updated
2026-01-26

Condition(s) studied

Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation

Investigational drug(s) / intervention(s)

ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg)high-intensity statin monotherapy (atoravastatin 40mg) →

ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg): The initial dose of lipid-lowering therapy will be ezetimibe 10mg plus atoravastatin 40mg. During follow-up, the dose of ezetimibe 10mg plus atoravastatin 40mg is strongly recommended to be maintained.

high-intensity statin monotherapy (atoravastatin 40mg): The initial dose of lipid-lowering therapy will be atoravastatin 40mg. During follow-up, the dose of atoravastatin 40mg is strongly recommended to be maintained.

Study summary

This study sought to evaluate whether ezetimibe combination to high-intensity statin therapy will have more prominent beneficial effect compared to high-intensity statin monotherapy in patients who underwent coronary revascularization with newer generation drug-eluting stent (DES) implantation. Furthermore, the optimal OCT-based optimal expansion criteria as well as the efficacy and safety of newer generation will be investigated.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age 19-85 years 2. Patients who underwent coronary revascularization with newer generation DES implantation Exclusion Criteria: 1. Allergy or hypersensitive to ezetimibe or statin 2. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range 3. History of any adverse drug reaction requiring discontinuation of statin 4. Pregnant women, women with potential childbearing, or lactating women 5. Life expectancy less than 3 years 6. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 7. Inability to understand or read the informed consent

Primary outcome measure(s)

  • Clinical efficacy of lipid lowering therapy — Within 3 years after the enrollment
    Composite of all-cause death, myocardial infarction (MI), any coronary revascularization, hospitalization for unstable angina, or nonfatal stroke within 3 years

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05782777 on ClinicalTrials.gov ↗ ← All trials in South Korea