Clinical Efficacy and sAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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The investigators evaluate the efficacy and safety of intravenous administration of nicorandil as adjuncts to reperfusion treatment in acute ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).

Official Title
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Impact of Intravenous Administration of Nicorandil as Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial

Conditions
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ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Nicorandil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years; acute ST-segment elevation myocardial infarction within 12 hours of symptom onset; Exclusion Criteria: systolic blood pressure<100mmHg; cardiac shock; aortic dissection; history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass grafting (<6 month); history of the treatment of nicorandil (<6 month); history of intravenous nitrates before percutaneous coronary intervention; contraindicated or intolerable to nicorandil; pregnant or lactation period; patients with an estimated survival time of less than 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention | Drug: Nicorandil<br>* 6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention<br>* Other names: intraveous nicorandil;|
| Placebo Comparator: Placebo arm<br>Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention | Drug: Placebo<br>* placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention<br>* Other names: intraveous palcebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure | 12 month after primary PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of slow re-flow/no-reflow | final coronary flow in the culprit artery | 3 minutes after primary PCI | 
| Rate fo complete ST-segment resolution | ST-segment resolution >50% in ECG | 2 hours after primary PCI | 
| Cardiac death | Cardiac death | 12 months after primary PCI | 
| Myocardial reinfarction | Myocardial reinfarction | 12 months after primary PCI | 
| Target vessel revascularization | Target vessel revascularization | 12 months after primary PCI | 
| Unplanned hospitalization for heart failure | Unplanned hospitalization for heart failure | 12 months after primary PCI |