About this trial
The aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 19 years old
Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information
Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease
maxLCBI4mm ≥354 in the culprit lesion measured by NIRS-IVUS
Disqualifiers
Patients with TIMI ≤ 2 before coronary intervention
Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.)
Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration
Trial design
Parallel
Treatments tested in this trial
Nicorandil
DrugAdminister 8cc or more of the prescribed drug according to randomization into the coronary artery before starting balloon therapy. The stent treatment method follows the standard treatment method.
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of decreased TIMI flow
occurrence of decreased TIMI flow (0,1,2) during the index procedure Grade 0-No perfusion Grade 1-Penetration without perfusion Grade 2-Partial perfusion but not reach complete perfusion Grade 3-Complete perfusion;; antegrade flow into the bed distal to the obstruction occurs as promptly as antegrade flow into the bed proximal to the obstruction, and clearance of contrast material from the involved bed is as rapid as clearance from an uninvolved bed in the same vessel or the opposite artery.
Secondary outcomes
Change of cardiac biomarker level after intervention
level change of CPK
Change of cardiac biomarker level after intervention
level change of CK-MB
Change of cardiac biomarker level after intervention
level change of Troponin T
Change of cardiac biomarker level after intervention
level change of Troponin I
Other outcomes
Association between lipid profile and lipid core burden index
Correlation among LDL-cholesterol, lipoprotein(a), pre-procedural LCBi max, Post-procedural LCBi, LCBi total burden
Sponsors and contacts
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Korea University Anam Hospital
Lead sponsor
Hanyang University Seoul Hospital
Collaborator
InjeUniversityIlsanPaikHospital
Collaborator
Ajou University School of Medicine
Collaborator