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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
nicorandil
placebo
Sponsored by
National Cerebral and Cardiovascular Center, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Data mining, Nicorandil, Randomized clinical trial, SNPs

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

estimated infarct size
left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion

Secondary Outcome Measures

survival rate
cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
the association of SNPs of ANP-related genes with response to ANP treatment

Full Information

First Posted
September 13, 2005
Last Updated
October 31, 2007
Sponsor
National Cerebral and Cardiovascular Center, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00212030
Brief Title
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Official Title
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cerebral and Cardiovascular Center, Japan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Data mining, Nicorandil, Randomized clinical trial, SNPs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
nicorandil
Intervention Description
(0∙067 mg/kg as a bolus, followed by 1∙67 μg/kg per min as a 24-h continuous intravenous infusion
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Control
Primary Outcome Measure Information:
Title
estimated infarct size
Time Frame
72hrs
Title
left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion
Time Frame
2-8weeks and 6-12months
Secondary Outcome Measure Information:
Title
survival rate
Time Frame
2.7years (median follow-up)
Title
cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
Time Frame
2.7years (median follow-up)
Title
reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
Time Frame
24hrs
Title
the association of SNPs of ANP-related genes with response to ANP treatment
Time Frame
2.7years (median follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masafumi Kitakaze, MD, PhD
Organizational Affiliation
National Cerebral and Cardiovascular Center, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
National Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
14745142
Citation
Minamino T, Jiyoong K, Asakura M, Shintani Y, Asanuma H, Kitakaze M; 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. doi: 10.1253/circj.68.101.
Results Reference
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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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