Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

Study Overview
=================
Brief Summary
-----------------
To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion

Detailed Description
-----------------
The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are limited by reperfusion injury. In animal models, nicorandil, a hybrid of an ATP-sensitive K+ (KATP) channel opener and nitrates, reduces infarct size, so the Japan-Working groups of acute myocardial Infarction for the reduction of Necrotic Damage by a K-ATP channel opener (J-WIND-KATP) designed a prospective, randomized, multicenter study to evaluate whether nicorandil reduces myocardial infarct size and improves regional wall motion when used as an adjunctive therapy for AMI. Twenty-six hospitals in Japan are participating in the J-WIND-KATP study. Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous nicorandil or placebo. The primary end-points are (1) estimated infarct size and (2) left ventricular function. Single nucleotide polymorphisms (SNPs) that may be associated with the function of KATP-channel and the susceptibility of AMI to the drug will be examined. Furthermore, a data mining method will be used to design the optimal combined therapy for post-myocardial infarction (MI) patients. It is intended that J-WIND-KATP will provide important data on the effects of nicorandil as an adjunct to PCI for AMI and that the SNPs information that will open the field of tailor-made therapy. The optimal therapeutic drug combination will also be determined for post-MI patients.

Official Title
-----------------
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: nicorandil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-79 years Chest pain of more than 30 min 0.1 mV ST-segment elevation in 2 contiguous ECG leads Admission to hospital within 12 h of symptom onset First episode of AMI Candidates for PCI Exclusion Criteria: History of old myocardial infarction Left main coronary artery stenosis Severe liver and/or kidney dysfunction Suspected aortic dissection History of coronary artery bypass graft History of allergic response to drugs Severe hypovolemia Right ventricular infarction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: nicorandil<br>* (0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* Control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated infarct size |  | 72hrs | 
| left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion |  | 2-8weeks and 6-12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | 2.7years (median follow-up) | 
| cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization) |  | 2.7years (median follow-up) | 
| reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain) |  | 24hrs | 
| the association of SNPs of ANP-related genes with response to ANP treatment |  | 2.7years (median follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Data mining, Nicorandil, Randomized clinical trial, SNPs