Trial | NCT00212030  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nicorandil ...

  • Study Participants

    600
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.
Study Started
Oct 31
2001
Study Completion
Dec 31
2005
Last Update
Nov 01
2007
Estimate

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

1 Active Comparator

2 Placebo Comparator

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
No Results Posted