UMIN-CTR Clinical Trial

Basic information
Public title	Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Acronym	J-WIND-KATP
Scientific Title	Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Scientific Title:Acronym	J-WIND-KATP
Region	Japan

Condition
Condition	Patients with AMI who are candidates for PCI(first episode of AMI)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	to evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) estimated infarct size and (2) left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion.
Key secondary outcomes	(1) survival rate (2)cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization) (3) reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain) (4) the association of SNPs of ANP-related genes with response to ANP treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In the nicorandil group, after a bolus injection of nicorandil(0.067 mg/kg), it is continuously infused intravenously at 1.67ug/kg·min for 24h.
Interventions/Control_2	In the control group, seline is continuously infused intravenously for 24h.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masafumi Kitakaze
Organization	National Cardiovascular Center
Division name	Cardiovascular Division
Zip code
Address	5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan
TEL	06-6833-5012
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Clinical Study Support Center Japan (CSSCJ)
Division name	J-WIND office
Zip code
Address
TEL	06-6836-0077
Homepage URL
Email

Sponsor
Institute	National Cardiovascular Center
Institute
Department

Funding Source
Organization	Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Lancet. 2008 Dec 22;370(9605):2102.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2001 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date	2001 Year 10 Month 01 Day
Last follow-up date	2007 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 08 Month 29 Day
Last modified on	2009 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000131

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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