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

Sponsored by:	National Cardiovascular Center, Japan
Information provided by:	National Cardiovascular Center, Japan
ClinicalTrials.gov Identifier:	NCT00212030

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

MedlinePlus related topics: Heart Attack

Drug Information available for: Nicorandil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

Further study details as provided by National Cardiovascular Center, Japan:

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
1: Active Comparator	Drug: nicorandil (0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion
2: Placebo Comparator	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:

Age 20-79 years
Chest pain of more than 30 min
0.1 mV ST-segment elevation in 2 contiguous ECG leads
Admission to hospital within 12 h of symptom onset
First episode of AMI
Candidates for PCI

Exclusion Criteria:

History of old myocardial infarction
Left main coronary artery stenosis
Severe liver and/or kidney dysfunction
Suspected aortic dissection
History of coronary artery bypass graft
History of allergic response to drugs
Severe hypovolemia
Right ventricular infarction

Contacts and Locations

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

Locations

Japan, OSAKA
National Cardiovascular Center
Suita, OSAKA, Japan, 565-8565

Sponsors and Collaborators

National Cardiovascular Center, Japan

Investigators

Study Chair:

Masafumi Kitakaze, MD, PhD

National Cardiovascular Center, Japan

More Information

Publications:

Minamino T, Jiyoong K, Asakura M, Shintani Y, Asanuma H, Kitakaze M; The 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.

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

Keywords provided by National Cardiovascular Center, Japan:

Acute myocardial infarction
Data mining
Nicorandil
Randomized clinical trial
SNPs

Study placed in the following topic categories:

Vasodilator Agents
Vitamin B Complex
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Trace Elements
Ischemia
Cardiovascular Agents

Antihypertensive Agents
Necrosis
Vitamins
Nicorandil
Micronutrients
Anti-Arrhythmia Agents
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Vasodilator Agents
Vitamin B Complex
Heart Diseases
Growth Substances
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Ischemia
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Necrosis
Pathologic Processes
Vitamins
Therapeutic Uses
Nicorandil
Cardiovascular Diseases
Micronutrients
Anti-Arrhythmia Agents
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009