NCT05427786RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 458 (estimated)
- First submitted
- 14 Jun 2022
- Start date
- Dec 2022
- Primary completion date
- May 2027
- Lead sponsor
- Korea University Anam Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05427786
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 458
- From Dec 2022 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration
Other illness
- 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.)
Age
- Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
Other
- Patients with TIMI ≤ 2 before coronary intervention
- 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
Who the study is looking for
- 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
- maxLCBI4mm ≥354 in the culprit lesion measured by NIRS-IVUS
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.