Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Korean Clinical Trials Database
Year
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2023
INTERVENTION: Drug : Among patients who underwent new‐generation drug‐eluting stent implantation, comparision between a group with ezetimibe 10mg/high‐intensity atorvastatin 40mg combination therapy orally administered once a day and a group with high‐intensity atorvastatin 40mg monotherapy once a day. CONDITION: Diseases of the circulatory system PRIMARY OUTCOME: Composite of all‐cause death, myocardial infarction (MI), any coronary revascularization, hospitalization for unstable angina, or nonfatal stroke SECONDARY OUTCOME: BARC type 2‐5 bleeding BARC type 3‐5 bleeding Cardiac death Change of proteinuria Device‐oriented composite endpoint (composite of cardiovascular death, MI, or clinically‐driven target‐vessel revascularization) Diagnosis of cancer Difference in clinical endpoints according to antiplatelet therapy strategy Difference in clinical endpoints according to high‐bleeding risks (high‐bleeding risk is defined according to ARC‐HBR criteria: meeting at least 1 major or 2 minor criteria) Difference in clinical endpoints according to high‐ischemic risks (high‐ischemic risk is defined as meeting one of the following: acute coronary syndrome, number of stents implanted =3, number of lesions treated =3, 3‐vessel treated, bifurcation percutaneous coronary intervention with 2 stents, total stent length =60mm, or chronic total occlusion) Difference in clinical endpoints according to the different OCT optimization criteria (absolute vs. relative stent expansion) when treating very long lesions (total stented length =40 mm) Each component of primary endpoint Elevation of hepatic enzymes (AST, ALT, or both > 3 XUNL) Elevation of muscle enzymes (CPK > 4 XUNL) Elevation of serum creatinine level (>50% from baseline) New‐onset diabetes mellitus, worsening of glycemic control, or homeostatic model assessment (HOMA)‐inde X Occurrence of statin‐associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage Operation due to cataract Patient‐oriented composite endpoint (composite of all‐cause death, MI, or any coronary revascularization) Proportion of subjects achieving target LDL‐cholesterol <55 mg/dL or 70 mg/dL at 6 weeks, 1, 2, and, 3 years Rate of cross‐over into the non‐allocated therapy regimen during follow‐up Safety endpoint related to lipid‐lowering medication Stent thrombosis (definite or probable) Target‐lesion revascularization Target‐vessel revascularization INCLUSION CRITERIA: 1. Age 19‐85 years 2. Patients who underwent coronary revascularization with newer generation DES implantation
Epistemonikos ID: fc3240d16fcae40dd7ec23677fbe0830229515b4
First added on: Feb 20, 2024