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Sponsored by: |
National Cardiovascular Center, Japan |
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Information provided by: | National Cardiovascular Center, Japan |
ClinicalTrials.gov Identifier: | NCT00212030 |
To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion
Condition | Intervention |
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Acute Myocardial Infarction |
Drug: nicorandil Drug: placebo |
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 |
Estimated Enrollment: | 600 |
Study Start Date: | October 2001 |
Study Completion Date: | December 2005 |
Arms | Assigned Interventions |
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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
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2: Placebo Comparator |
Drug: placebo
Control
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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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, OSAKA | |
National Cardiovascular Center | |
Suita, OSAKA, Japan, 565-8565 |
Study Chair: | Masafumi Kitakaze, MD, PhD | National Cardiovascular Center, Japan |
Study ID Numbers: | CSSCJ-2, UMIN_ID:C000000089 |
Study First Received: | September 13, 2005 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00212030 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Acute myocardial infarction Data mining Nicorandil Randomized clinical trial SNPs |
Necrosis Heart Diseases Myocardial Ischemia Nicorandil |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Vasodilator Agents Vitamin B Complex Growth Substances Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Pathologic Processes Therapeutic Uses Vitamins Cardiovascular Diseases Anti-Arrhythmia Agents Micronutrients |