What is nicorandil studying for coronary artery disease?

Nicorandil is being studied to see if injecting it into the coronary artery before stent treatment can prevent lowered blood flow during the procedure in patients with coronary artery disease. The study aims to improve safety during percutaneous coronary intervention and is sponsored by Korea University Anam Hospital. Participants receive careful monitoring to assess blood flow and heart health.

Who may be eligible for this coronary artery disease clinical trial?

Adults aged 19 years or older who require stent surgery guided by NIRS-IVUS for coronary artery disease may be eligible. Participants must agree to the study and follow-up plans and not have allergies to key heart medications or contrast agents. Pregnant or breastfeeding women are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this coronary artery disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from the study sites may vary and are not guaranteed to be covered. Participants can plan accordingly for any travel arrangements.

Actively Recruiting

Phase 4

Age: 19Years +

All Genders

ID05427786

A Randomized, Open Label, Parallel-group Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to Prevent Reduced TIMI Flow in Patients Undergoing Percutaneous Coronary Intervention for Coronary Artery Disease

Led by Korea University Anam Hospital · Updated on 2024-10-10

460

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years +

All Genders

Eligibility Criteria

You may qualify if you...

Over 19 years old
Patients who agree to the study and clinical follow-up plan and provide written consent
Patients who have undergone NIRS-IVUS guided coronary stent surgery for coronary artery disease

You will not qualify if you...

Patients with TIMI flow less than or equal to 2 before coronary intervention
Known allergies or contraindications to heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel, or contrast agents (except controlled hypersensitivity to contrast agents)
Pregnant or breastfeeding women, or women planning pregnancy during the study
Patients planning surgery to stop antiplatelet drugs within 6 months from registration
Patients expected to survive less than 1 year
Patients admitted due to cardiogenic shock with low survival probability according to medical judgment

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