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NCT Number: NCT05782777

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 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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Byeong-Keuk Kim

CONTACT

[email protected]

82-2228-8460

About this study

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, we 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 ≥30 mm (targeted for 700 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". The absolute expansion criteria is defined as a minimum stent area (MSA) >4.5mm2, while the relative expansion criteria is defined as achieving an MSA ≥ 80% of the mean reference lumen area or ≥ 100% of the distal reference lumen area. The patients will receive DES implantation under OCT guidance and stent optimization will be performed to satisfy the assigned expansion criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Drug

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.

high-intensity statin monotherapy (atoravastatin 40mg)

Drug

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.

Primary outcomes

  1. Clinical efficacy of lipid lowering therapy

    Time frame: Within 3 years after the enrollment

    Composite of all-cause death, myocardial infarction (MI), any coronary revascularization, hospitalization for unstable angina, or nonfatal stroke within 3 years

Secondary outcomes

  1. Proportion of subjects achieving target LDL-cholesterol <55 mg/dL or 70 mg/dL at 6 weeks, 1, 2, and, 3 years

    Time frame: Within 3 years after the enrollment

  2. Rate of cross-over into the non-allocated therapy

    Time frame: Within 3 years after the enrollment

  3. Each component of primary endpoint A. All-cause death (percentage)

    Time frame: Within 3 years after the enrollment

  4. Each component of primary endpoint B. MI (percentage)

    Time frame: Within 3 years after the enrollment

  5. Each component of primary endpoint C. Any coronary revascularization (percentage)

    Time frame: Within 3 years after the enrollment

  6. Each component of primary endpoint D. Hospitalization for unstable angina (percentage)

    Time frame: Within 3 years after the enrollment

  7. Each component of primary endpoint E. Nonfatal-stroke (percentage)

    Time frame: Within 3 years after the enrollment

  8. Cardiac death (percentage)

    Time frame: Within 3 years after the enrollment

  9. Stent thrombosis (percentage)

    Time frame: Within 3 years after the enrollment

  10. Target-vessel revascularization (percentage)

    Time frame: Within 3 years after the enrollment

  11. Target-lesion revascularization (percentage)

    Time frame: Within 3 years after the enrollment

  12. BARC type 2-5 bleeding (percentage)

    Time frame: Within 3 years after the enrollment

  13. BARC type 3-5 bleeding (percentage)

    Time frame: Within 3 years after the enrollment

  14. Patient-oriented composite endpoint which is composite of all-cause death, MI, or any coronary revascularization (percentage)

    Time frame: Within 3 years after the enrollment

  15. Device-oriented composite endpoint which is composite of cardiovascular death, MI, or clinically-driven target-vessel revascularization (percentage)

    Time frame: Within 3 years after the enrollment

  16. Difference in antiplatelet therapy strategy (percentage)

    Time frame: Within 3 years after the enrollment

  17. Difference in high-ischemic risks (percentage)

    Time frame: Within 3 years after the enrollment

  18. Difference in high-bleeding risks (percentage)

    Time frame: Within 3 years after the enrollment

  19. different OCT optimization criteria when treating very long lesions

    Time frame: Within 3 years after the enrollment

    A. Primary endpoint (percentage) B. Stent thrombosis (percentage) C. Target-vessel revascularization (percentage) D. Target-lesion revascularization (percentage) E. Patient-oriented composite endpoint (percentage) F. Device-oriented composite endpoint ((percentage)

  20. Safety endpoint related to lipid-lowering medication

    Time frame: Within 3 years after the enrollment

    A. New-onset DM, worsening of glycemic control or HOMA-index (percentage) B. Occurrence of SAMS requiring change of therapy regimen or dosage (percentage) C. Elevation of muscle enzymes which is creatine kinase > 4 x Upper Normal Limit (percentage) D. Elevation of hepatic enzymes which is aminotransferase > 3 x Upper Normal Limit (percentage) E. Elevation of serum creatinine level which is > 50% from baseline (percentage) F. Increase of proteinuria (percentage) G. Diagnosis of cancer (percentage)

Study contacts

Contact information is provided by the study sponsor or research team.

Byeong-Keuk Kim

CONTACT

[email protected]

82-2228-8460

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2023
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.