Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction

Study Overview
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Brief Summary
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The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in patient with ST-segment elevation acute myocardial infarction.

Detailed Description
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Study objective : To investiage whether nicorandil treatment reduce infarct size measured by cardiac MRI at 6 months after primary PCI Allocation : Nicorandil arm : Recieve nicorandil 4 mg i.v. before undergoing PCI, additionall 2mg i.c. just before 1st ballooning, additionall 2mg i.c. just before stenting, After successful PCI, 10 mg/day (or 5 mg/day) p.o. for 6 months. Control arm : Recieve standard treatment including PCI, but avoid nicoranil and adenosine. Follow-up and Measurement : Cardiac MRI scans are scheduled at 5 days and 6 months after primary PCI. Clinically followed upto 6 months after parimary PCI.

Official Title
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Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction : A Randomized Clinical Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Nicorandil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI patients presenting within 12 hours after symptom onset Undergoing primary PCI Exclusion Criteria: Previous myocardial infarction Atrial fibrillation RV infarction Cardiogenic shock Serum creatinine >2.0 mg/dL Narrow angle glaucoma Taking PDE-5 inhibitors

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicorandil<br>Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy. | Drug: Nicorandil<br>* 4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting<br>* Other names: Nicrodandil;|
| No Intervention: Control<br>Receive primary PCI and the standard therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size as measured by cardiac MRI |  | Six months after primary PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF(%) as measured by cardiac MRI |  | Five days and 6 months after primary PCI | 
| MVO as measured by cardiac MRI |  | Five days after primary PCI | 
| ST-segment resolution |  | One hour after primary PCI | 
| MACE (Death, Spontaneous MI, Stroke) |  | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicorandil, Cardiac MRI