Study on Preventing Reduced Coronary Blood Flow Using Nicorandil Injection Before Stent Treatment in Patients with Coronary Artery Disease

What this Trial Is About

This research aims to evaluate the effect of injecting nicorandil directly into the coronary artery before percutaneous coronary intervention PCI in patients with coronary artery disease who have high-risk plaques. The study focuses on preventing a decrease in coronary blood flow, measured by the TIMI flow, during the procedure. Participants are patients requiring stent treatment with a high lipid core burden index at the main lesion site. Participants with a lipid core burden index above 353 are randomly assigned to one of two groups. One group receives an intracoronary injection of at least 8cc of nicorandil before balloon therapy during PCI. The other group undergoes the standard PCI procedure without the nicorandil injection. The stent treatment method follows the usual clinical practice in both groups. During the study, researchers will monitor the occurrence of decreased TIMI flow during the procedure as the primary outcome. Secondary outcomes include changes in cardiac biomarker levels one month after intervention and several patient health measures such as mortality, cardiac death, myocardial infarction, and revascularization rates over one year. The study involves clinical follow-up and written consent for data use from participants, with the total duration including at least one year of follow-up.

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