RecruitingNot ApplicableNCT05782777

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


Sponsor

Yonsei University

Enrollment

4,310 participants

Start Date

Apr 7, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study, called the ESCORT Trial, is comparing two strategies for lowering cholesterol after a common heart procedure called percutaneous coronary intervention (PCI), where doctors place a small mesh tube (stent) in a blocked heart artery to restore blood flow. The question being investigated is whether combining a high-intensity statin (a cholesterol-lowering drug) with another medication called ezetimibe works better than taking a high-intensity statin alone. The study is open to men and women between the ages of 19 and 85 who recently had a newer-generation drug-eluting stent placed in their coronary arteries. People with liver disease, a history of allergic reactions to these medications, pregnant or breastfeeding women, or those with a life expectancy under three years are not eligible. Participants will be assigned to one of two groups and followed for one year to compare how well each approach lowers LDL ("bad") cholesterol and reduces the risk of future heart events. The findings could help doctors fine-tune cholesterol management for the millions of people who undergo stent procedures each year, ultimately reducing heart attacks and improving long-term outcomes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGezetimibe/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.

DRUGhigh-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.


Locations(1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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NCT05782777