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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212030
• Other study ID #: CSSCJ-2
• Secondary ID: UMIN_ID:C0000000
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 31, 2007
• Start date: October 2001
• Est. completion date: December 2005

Study information

• Verified date: October 2007
• Source: National Cerebral and Cardiovascular Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Japan	National Cardiovascular Center	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Minamino T, Jiyoong K, Asakura M, Shintani Y, Asanuma H, Kitakaze M; J-WIND Investigators. Rationale and design of a large-scale trial using nicorandil as an adjunct to percutaneous coronary intervention for ST-segment elevation acute myocardial infarction: Japan-Working groups of acute myocardial infarction for the reduction of Necrotic Damage by a K-ATP channel opener (J-WIND-KATP). Circ J. 2004 Feb;68(2):101-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimated infarct size		72hrs
Primary	left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion		2-8weeks and 6-12months
Secondary	survival rate		2.7years (median follow-up)
Secondary	cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)		2.7years (median follow-up)
Secondary	reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)		24hrs
Secondary	the association of SNPs of ANP-related genes with response to ANP treatment		2.7years (median follow-up)