Acute Myocardial Infarction Clinical Trial
Official title:
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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