A Phase 4 interventional study of Nicorandil in No-Reflow Phenomenon, Coronary Artery Disease and Percutaneous Coronary Intervention, sponsored by Korea University Anam Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Korea University Anam Hospital · Phase 4, Interventional, and Prevention
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.
27 studies on the registry are indexed under No-Reflow Phenomenon; 9 are open to participants now.
This study's planned enrollment of 458 is above the median of 201 across 19 interventional studies indexed under No-Reflow Phenomenon.
Browse No-Reflow Phenomenon studies →Korea University Anam Hospital is the lead sponsor of 112 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Nicorandil group will be administrated 8cc or more of the prescribed drug (Nicroandil) according to randomization into the coronary artery before starting balloon therapy.
Drug: Nicorandil
If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed. Standard PCI group will be performed coronary intervention including starting balloon therapy without pre-administrated 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.
Occurrence of decreased TIMI flow
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.
Time frame: during procedure
Change of cardiac biomarker level after intervention
level change of CPK
Time frame: 1 month
Change of cardiac biomarker level after intervention
level change of CK-MB
Time frame: 1 month
Change of cardiac biomarker level after intervention
level change of Troponin T
Time frame: 1 month
Change of cardiac biomarker level after intervention
level change of Troponin I
Time frame: 1 month
patient-oriented composite end point
composite of all cause mortality, any myocardial infarction, and any revascularization
Time frame: 1 year
Percentage of All cause mortality
Time frame: 1 year
Percentage of cardiac death
Time frame: 1 year
Percentage of myocardial infarction
Time frame: 1 year
Percentage of revascularization
Time frame: 1 year
Association between lipid profile and lipid core burden index
Correlation among LDL-cholesterol, lipoprotein(a), pre-procedural LCBi max, Post-procedural LCBi, LCBi total burden
Time frame: 6 month
Plan to share: No — The data generated in this study is available from the corresponding author(s) upon reasonable request.
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Studies of the drug tested here: Nicorandil
Korea University Anam Hospital →