RecruitingPhase 4

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

South Korea460 participantsStarted 2022-12-14

Plain-language summary

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.

Who can participate

Age range19 Years

SexALL

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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

What they're measuring

Occurrence of decreased TIMI flow

Timeframe: during procedure

Trial details

NCT IDNCT05427786

SponsorKorea University Anam Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

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