NCT05427786 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
| NCT ID | NCT05427786 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Korea University Anam Hospital |
| Condition | No-Reflow Phenomenon |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2022-12-14 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 460 participants in total. It began in 2022-12-14 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT05427786 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying No-Reflow Phenomenon. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05427786 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05427786 currently recruiting?
Yes, NCT05427786 is actively recruiting participants. Visit ClinicalTrials.gov or contact Korea University Anam Hospital to inquire about joining.
Where is the NCT05427786 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05427786 clinical trial?
NCT05427786 is sponsored by Korea University Anam Hospital. The trial plans to enroll 460 participants.