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

• estimated infarct size [ Time Frame: 72hrs ]
• left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion [ Time Frame: 2-8weeks and 6-12months ]

• (1) estimated infarct size and
• (2) left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion.

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

• (1) survival rate
• (2)cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
• (3) reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
• (4) the association of SNPs of ANP-related genes with response to ANP treatment

To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion

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.

• Drug: nicorandil
  (0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion
• Drug: placebo
  Control

• Active Comparator: 1
  Intervention: Drug: nicorandil
• Placebo Comparator: 2
  Intervention: Drug: placebo

Inclusion Criteria:

1. Age 20-79 years
2. Chest pain of more than 30 min
3. 0.1 mV ST-segment elevation in 2 contiguous ECG leads
4. Admission to hospital within 12 h of symptom onset
5. First episode of AMI
6. Candidates for PCI

Exclusion Criteria:

1. History of old myocardial infarction
2. Left main coronary artery stenosis
3. Severe liver and/or kidney dysfunction
4. Suspected aortic dissection
5. History of coronary artery bypass graft
6. History of allergic response to drugs
7. Severe hypovolemia
8. Right ventricular infarction