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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212030

Enrollment

600

Registered

2005-09-21

Start date

2001-10-31

Completion date

2005-12-31

Last updated

2007-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction, Data mining, Nicorandil, Randomized clinical trial, SNPs

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.

Interventions

DRUGnicorandil

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

DRUGplacebo

Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026