Comparing high-intensity statin with ezetimibe to statin alone after heart stent placement
Official title: 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
Run by Yonsei University · NCT05782777 · Data updated 2026-11-12
This study is testing if adding ezetimibe to high-intensity statin treatment helps people feel better after getting a heart stent compared to just using high-intensity statins alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 4310 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | April 7, 2023 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT05782777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19-85 who have undergone coronary revascularization with newer generation DES implantation.
✕Probably not a fit
Patients with allergies to ezetimibe or statins, active liver disease, or those who cannot adhere to follow-up may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of combining ezetimibe with high-intensity statin therapy compared to high-intensity statin monotherapy in patients who have undergone coronary revascularization with newer generation drug-eluting stents (DES). Eligible patients will be stratified based on their LDL-cholesterol levels and assigned randomly to either the combination therapy group or the statin monotherapy group. Additionally, an OCT substudy will assess stent expansion criteria in patients with long lesions requiring extensive stenting. The study aims to enroll around 1000 patients and will monitor their outcomes over a year.
Why it matters
Potential benefit: If successful, this approach could lead to improved cardiovascular outcomes for patients undergoing coronary revascularization.
How similar studies have gone: Previous studies have shown promising results with similar lipid-lowering combination therapies, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Yonsei University Health System, Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Byeong-Keuk Kim — Severance Cardiovascular Hospital, Yonsei University Health System
- Study coordinator: Byeong-Keuk Kim
- Email: kimbk@yuhs.ac
- Phone: 82-2228-8460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.