Comparing high-intensity statin with ezetimibe to statin alone after heart stent placement
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4310 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05782777 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-85 who have undergone coronary revascularization with newer generation DES implantation.
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.
Why it matters
Potential benefit: If successful, this approach could lead to improved cardiovascular outcomes for patients undergoing coronary revascularization.
How similar studies have performed: Previous studies have shown promising results with similar lipid-lowering combination therapies, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.