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

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ClinicalTrials.gov Identifier: NCT00212030
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 1, 2007
Information provided by:

Study Description
Brief Summary:
To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion

Condition or disease Intervention/treatment
Acute Myocardial Infarction Drug: nicorandil 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Study Start Date : October 2001
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. estimated infarct size [ Time Frame: 72hrs ]
  2. 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 :
  1. survival rate [ Time Frame: 2.7years (median follow-up) ]
  2. cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization) [ Time Frame: 2.7years (median follow-up) ]
  3. reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain) [ Time Frame: 24hrs ]
  4. the association of SNPs of ANP-related genes with response to ANP treatment [ Time Frame: 2.7years (median follow-up) ]

Eligibility Criteria

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00212030     History of Changes
Other Study ID Numbers: CSSCJ-2
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 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