A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label, Parallel-group Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease

Conditions
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No-Reflow Phenomenon, Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Nicorandil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Those whose surviving life is expected to be less than 1 year Subjects who visited the hospital due to cardiogenic shock and are predicted to have low survival probability based on medical judgment

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-PCI IC Nicorandil<br>If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Nicorandil group will be administrated 8cc or more of the prescribed drug (Nicroandil) according to randomization into the coronary artery before starting balloon therapy. | Drug: Nicorandil<br>* Administer 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.<br>|
| No Intervention: Standard PCI<br>If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Standard PCI group will be performed coronary intervention including starting balloon therapy without pre-administrated nicorandil. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cardiac biomarker level after intervention | level change of CPK | 1 month | 
| Change of cardiac biomarker level after intervention | level change of CK-MB | 1 month | 
| Change of cardiac biomarker level after intervention | level change of Troponin T | 1 month | 
| Change of cardiac biomarker level after intervention | level change of Troponin I | 1 month | 
| patient-oriented composite end point | composite of all cause mortality, any myocardial infarction, and any revascularization | 1 year | 
| Percentage of All cause mortality |  | 1 year | 
| Percentage of cardiac death |  | 1 year | 
| Percentage of myocardial infarction |  | 1 year | 
| Percentage of revascularization |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicorandil, No-reflow phenomenon, lipid core burden index, near-infrared spectroscopy