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

Inclusion Criteria2

  • Age 19-85 years
  • Patients who underwent coronary revascularization with newer generation DES implantation

Exclusion Criteria7

  • Allergy or hypersensitive to ezetimibe or statin
  • Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
  • History of any adverse drug reaction requiring discontinuation of statin
  • Pregnant women, women with potential childbearing, or lactating women
  • Life expectancy less than 3 years
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Inability to understand or read the informed consent

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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