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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000088
Receipt No. R000000130
Scientific Title Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Date of disclosure of the study information 2005/08/31
Last modified on 2009/12/22

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Basic information
Public title Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Acronym J-WIND-ANP
Scientific Title Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Scientific Title:Acronym J-WIND-ANP
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 ANP as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
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
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 ANP group, ANP is continuously infused intravenously at 0.025mg·kg–1·min–1 for 3 days
Interventions/Control_2 Glucose solution is continuously infused intravenously
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
2006 Year 09 Month 01 Day

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=R000000130

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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