Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 4310
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Clinical efficacy of lipid lowering therapy
timeFrame: Within 3 years after the enrollment
Secondary outcomes:
measure: Proportion of subjects achieving target LDL-cholesterol <55 mg/dL or 70 mg/dL at 6 weeks, 1, 2, and, 3 years
timeFrame: Within 3 years after the enrollment
measure: Rate of cross-over into the non-allocated therapy
timeFrame: Within 3 years after the enrollment
measure: Each component of primary endpoint A. All-cause death (percentage)
timeFrame: Within 3 years after the enrollment
measure: Each component of primary endpoint B. MI (percentage)
timeFrame: Within 3 years after the enrollment
measure: Each component of primary endpoint C. Any coronary revascularization (percentage)
timeFrame: Within 3 years after the enrollment
measure: Each component of primary endpoint D. Hospitalization for unstable angina (percentage)
timeFrame: Within 3 years after the enrollment
measure: Each component of primary endpoint E. Nonfatal-stroke (percentage)
timeFrame: Within 3 years after the enrollment
measure: Cardiac death (percentage)
timeFrame: Within 3 years after the enrollment
measure: Stent thrombosis (percentage)
timeFrame: Within 3 years after the enrollment
measure: Target-vessel revascularization (percentage)
timeFrame: Within 3 years after the enrollment
measure: Target-lesion revascularization (percentage)
timeFrame: Within 3 years after the enrollment
measure: BARC type 2-5 bleeding (percentage)
timeFrame: Within 3 years after the enrollment
measure: BARC type 3-5 bleeding (percentage)
timeFrame: Within 3 years after the enrollment
measure: Patient-oriented composite endpoint which is composite of all-cause death, MI, or any coronary revascularization (percentage)
timeFrame: Within 3 years after the enrollment
measure: Device-oriented composite endpoint which is composite of cardiovascular death, MI, or clinically-driven target-vessel revascularization (percentage)
timeFrame: Within 3 years after the enrollment
measure: Difference in antiplatelet therapy strategy (percentage)
timeFrame: Within 3 years after the enrollment
measure: Difference in high-ischemic risks (percentage)
timeFrame: Within 3 years after the enrollment
measure: Difference in high-bleeding risks (percentage)
timeFrame: Within 3 years after the enrollment
measure: different OCT optimization criteria when treating very long lesions
timeFrame: Within 3 years after the enrollment
measure: Safety endpoint related to lipid-lowering medication
timeFrame: Within 3 years after the enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Cardiovascular Hospital, Yonsei University Health System
name: Byeong-Keuk Kim
role: PRINCIPAL_INVESTIGATOR
References: