Evaluating Nicorandil to Prevent Blood Flow Issues During Heart Procedures
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
This study is testing if a medication called nicorandil can help people with high-risk heart plaque maintain better blood flow during heart procedures like stent placement.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Drugs / interventions | evolocumab |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05427786 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of intracoronary nicorandil injection on preventing reduced blood flow in patients undergoing percutaneous coronary intervention for coronary artery disease. It specifically targets patients with high-risk plaque lesions, identified by a high lipid core burden index. The study aims to determine if nicorandil can improve outcomes by maintaining coronary blood flow during stent placement. Participants will be monitored for their response to the treatment and overall procedural success.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old who are undergoing NIRS-IVUS guided coronary stent surgery for coronary artery disease.
Not a fit: Patients with pre-existing low TIMI flow or known hypersensitivity to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve blood flow and outcomes for patients undergoing heart procedures.
How similar studies have performed: While the specific use of nicorandil in this context may be novel, similar studies have shown promising results in improving coronary blood flow during interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.