Yonsei University Health System, Severance Hospital
Seoul, South Korea
Location status: Recruiting
NCT Number: NCT05782777
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
Time frame: Within 3 years after the enrollment
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)
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)
Contact information is provided by the study sponsor or research team.
Yonsei University
Other
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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.