Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES ImplantationNCT05782777
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
A study testing ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg) and high-intensity statin monotherapy (atoravastatin 40mg) in people with Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
- What is being tested?
- ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg) and high-intensity statin monotherapy (atoravastatin 40mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,310 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-85 years
- Patients who underwent coronary revascularization with newer generation DES implantation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Byeong-Keuk Kim, 82-2228-8460, kimbk@yuhs.ac
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
- Being tested
- ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg), high-intensity statin monotherapy (atoravastatin 40mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy group | Experimental | Ezetimibe/high-intensity statin combination therapy Receives: Drug: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg) |
| Statin monotherapy group | Active comparator | High-intensity statin monotherapy Receives: Drug: high-intensity statin monotherapy (atoravastatin 40mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of lipid lowering therapy
Composite of all-cause death, myocardial infarction (MI), any coronary revascularization, hospitalization for unstable angina, or nonfatal stroke within 3 years
Measured: Within 3 years after the enrollment
Secondary outcomes (20)
Proportion of subjects achieving target LDL-cholesterol <55 mg/dL or 70 mg/dL at 6 weeks, 1, 2, and, 3 years
Measured: Within 3 years after the enrollment
Rate of cross-over into the non-allocated therapy
Measured: Within 3 years after the enrollment
Each component of primary endpoint A. All-cause death (percentage)
Measured: Within 3 years after the enrollment
Each component of primary endpoint B. MI (percentage)
Measured: Within 3 years after the enrollment
Each component of primary endpoint C. Any coronary revascularization (percentage)
Measured: Within 3 years after the enrollment
Each component of primary endpoint D. Hospitalization for unstable angina (percentage)
Measured: Within 3 years after the enrollment
Each component of primary endpoint E. Nonfatal-stroke (percentage)
Measured: Within 3 years after the enrollment
Cardiac death (percentage)
Measured: Within 3 years after the enrollment
Stent thrombosis (percentage)
Measured: Within 3 years after the enrollment
Target-vessel revascularization (percentage)
Measured: Within 3 years after the enrollment
Target-lesion revascularization (percentage)
Measured: Within 3 years after the enrollment
BARC type 2-5 bleeding (percentage)
Measured: Within 3 years after the enrollment
BARC type 3-5 bleeding (percentage)
Measured: Within 3 years after the enrollment
Patient-oriented composite endpoint which is composite of all-cause death, MI, or any coronary revascularization (percentage)
Measured: Within 3 years after the enrollment
Device-oriented composite endpoint which is composite of cardiovascular death, MI, or clinically-driven target-vessel revascularization (percentage)
Measured: Within 3 years after the enrollment
Difference in antiplatelet therapy strategy (percentage)
Measured: Within 3 years after the enrollment
Difference in high-ischemic risks (percentage)
Measured: Within 3 years after the enrollment
Difference in high-bleeding risks (percentage)
Measured: Within 3 years after the enrollment
different OCT optimization criteria when treating very long lesions
- 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)
Measured: Within 3 years after the enrollment
Safety endpoint related to lipid-lowering medication
- 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)
Measured: Within 3 years after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start7 Apr 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES ImplantationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeong-Keuk Kim, Principal investigator, Severance Cardiovascular Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782777
- Sponsor's protocol ID
- 4-2022-1335
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05782777
- Acronym / sponsor ID
- 4-2022-1335
- Conditions
- Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,310 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy group | Experimental | Drug: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg)Ezetimibe/high-intensity statin combination therapy |
| Statin monotherapy group | Active comparator | Drug: high-intensity statin monotherapy (atoravastatin 40mg)High-intensity statin monotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19-85 years
- Patients who underwent coronary revascularization with newer generation DES implantation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Combination therapy group |
| 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. | Drug | Statin monotherapy group |
Primary outcome
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
20 secondary outcomes
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
BARC type 3-5 bleeding (percentage)
Time frame: Within 3 years after the enrollment
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
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
Difference in antiplatelet therapy strategy (percentage)
Time frame: Within 3 years after the enrollment
Difference in high-ischemic risks (percentage)
Time frame: Within 3 years after the enrollment
Difference in high-bleeding risks (percentage)
Time frame: Within 3 years after the enrollment
different OCT optimization criteria when treating very long lesions
Time frame: Within 3 years after the enrollment
Safety endpoint related to lipid-lowering medication
Time frame: Within 3 years after the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Byeong-Keuk Kim principal investigator
Severance Cardiovascular Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg) and high-intensity statin monotherapy (atoravastatin 40mg) in people with Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Byeong-Keuk Kim (82-2228-8460, kimbk@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of lipid lowering therapy (time frame: Within 3 years after the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.