Clinical Trials in South Korea / NCT05427786
Recruiting
Phase 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
NCT05427786 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
No-Reflow PhenomenonCoronary Artery DiseasePercutaneous Coronary Intervention
Investigational drug(s) / intervention(s)
Nicorandil: 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.
Study 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.
Eligibility
Inclusion Criteria:
1. Over 19 years old
2. 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
3. Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease
4. maxLCBI4mm ≥354 in the culprit lesion measured by NIRS-IVUS
Exclusion Criteria:
1. Patients with TIMI ≤ 2 before coronary intervention
2. 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.)
3. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
4. Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration
5. Those whose surviving life is expected to be less than 1 year
6. Subjects who visited the hospital due to cardiogenic shock and are predicted to have low survival probability based on medical judgment
Primary outcome measure(s)
- Occurrence of decreased TIMI flow — during procedure
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea | Recruiting |
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Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05427786 on ClinicalTrials.gov ↗ ← All trials in South Korea