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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg), high-intensity statin monotherapy (atoravastatin 40mg).
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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, 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.
Interventions
- Drug ezetimibe/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. - Drug high-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.
Primary outcome measures
- Clinical efficacy of lipid lowering therapy [Time frame: Within 3 years after the enrollment]
Secondary outcome measures (12)
- 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]
- Rate of cross-over into the non-allocated therapy [Time frame: Within 3 years after the enrollment]
- Each component of primary endpoint A. All-cause death (percentage) [Time frame: Within 3 years after the enrollment]
- Each component of primary endpoint B. MI (percentage) [Time frame: Within 3 years after the enrollment]
- Each component of primary endpoint C. Any coronary revascularization (percentage) [Time frame: Within 3 years after the enrollment]
- Each component of primary endpoint D. Hospitalization for unstable angina (percentage) [Time frame: Within 3 years after the enrollment]
- Each component of primary endpoint E. Nonfatal-stroke (percentage) [Time frame: Within 3 years after the enrollment]
- Cardiac death (percentage) [Time frame: Within 3 years after the enrollment]
- Stent thrombosis (percentage) [Time frame: Within 3 years after the enrollment]
- Target-vessel revascularization (percentage) [Time frame: Within 3 years after the enrollment]
- Target-lesion revascularization (percentage) [Time frame: Within 3 years after the enrollment]
- BARC type 2-5 bleeding (percentage) [Time frame: Within 3 years after the enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei University Health System, Severance Hospital — Seoul
Identifiers
NCT: NCT05782777 · 4-2022-1335