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

This study has been completed.
Information provided by:
National Cerebral and Cardiovascular Center Identifier:
First received: September 13, 2005
Last updated: October 31, 2007
Last verified: October 2007
To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion

Condition Intervention
Acute Myocardial Infarction
Drug: nicorandil
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

Resource links provided by NLM:

Further study details as provided by National Cerebral and Cardiovascular Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 600
Study Start Date: October 2001
Study Completion Date: December 2005
Arms Assigned Interventions
Active Comparator: 1 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 Comparator: 2 Drug: placebo

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.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00212030

National Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Study Chair: Masafumi Kitakaze, MD, PhD National Cerebral and Cardiovascular Center
  More Information

Publications: Identifier: NCT00212030     History of Changes
Other Study ID Numbers: CSSCJ-2
Study First Received: September 13, 2005
Last Updated: October 31, 2007

Keywords provided by National Cerebral and Cardiovascular Center:
Acute myocardial infarction
Data mining
Randomized clinical trial

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on May 25, 2017