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
NCT ID: NCT05782777
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4310 participants
INTERVENTIONAL
2023-04-07
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination therapy group
Ezetimibe/high-intensity statin combination therapy
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.
Statin monotherapy group
High-intensity statin monotherapy
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients who underwent coronary revascularization with newer generation DES implantation
Exclusion Criteria
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
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Byeong-Keuk Kim
Role: PRINCIPAL_INVESTIGATOR
Severance Cardiovascular Hospital, Yonsei University Health System
Locations
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Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2022-1335
Identifier Type: -
Identifier Source: org_study_id
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