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

Last updated: March 13, 2024
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Thrombosis

Vascular Diseases

Treatment

high-intensity statin monotherapy (atoravastatin 40mg)

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

Clinical Study ID

NCT05782777
4-2022-1335
  • Ages > 19
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 19-85 years
  2. Patients who underwent coronary revascularization with newer generation DESimplantation

Exclusion

Exclusion Criteria:

  1. Allergy or hypersensitive to ezetimibe or statin
  2. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2times 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, asassessed by the investigator
  7. Inability to understand or read the informed consent

Study Design

Total Participants: 4310
Treatment Group(s): 2
Primary Treatment: high-intensity statin monotherapy (atoravastatin 40mg)
Phase:
Study Start date:
April 07, 2023
Estimated Completion Date:
December 31, 2027

Study Description

All eligible patients who underwent coronary revascularization with newer generation DES implantation will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent. At the time of enrollment, the investigators will stratify the patients according to LDL-cholesterol <100mg/dL, acute coronary syndrome, and DES type, and randomly assign them in two groups according to lipid-lowering therapy with a 1:1 ratio: "Combination therapy group" vs. "Statin monotherapy group". In this study, four types of new generation DES will be used: Orsiro (Biotronik), Firehawk (Microport), Genoss (Genoss) or D+Storm (CGBIO).

In this study, OCT substudy will be performed for the patients with diffuse long lesions requiring total stented length ≥40 mm (targeted for 1000 patients in the trial). Corresponding patients will be randomly assigned into two groups according to the OCT-based optimal expansion criteria with a 1:1 ratio: meeting "Absolute expansion" vs. "Relative expansion". Absolute expansion criteria indicate minimum stent area (MSA) >4.5mm2 and relative expansion criteria indicate MSA > 80% of average reference lumen area. The patients will receive DES implantation under OCT guidance and stent optimization will be performed to satisfy each expansion criteria.

Connect with a study center

  • Yonsei University Health System, Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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