UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000088 |
|---|---|
| Receipt number | 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 21:59:19 |
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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
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
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000130
