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

This study has been completed.
Sponsor:
Information provided by:
National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier:
NCT00212030
First received: September 13, 2005
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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
Control

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212030

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

Publications:
ClinicalTrials.gov Identifier: NCT00212030     History of Changes
Other Study ID Numbers: CSSCJ-2, UMIN_ID:C000000089
Study First Received: September 13, 2005
Last Updated: October 31, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Nicorandil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014