UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000229 |
|---|---|
| Receipt number | R000000294 |
| Scientific Title | Evaluating safety and efficacy of low dose monteplase and nicorandil injected before percutaneous coronary intervention on left ventricular wall motion in patients of acute myocardial infarction:a randomized study. |
| Date of disclosure of the study information | 2005/09/14 |
| Last modified on | 2016/10/13 13:04:59 |
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Basic information
Public title
Evaluating safety and efficacy of low dose monteplase and nicorandil injected before percutaneous coronary intervention on left ventricular wall motion in patients of acute myocardial infarction:a randomized study.
Acronym
Injection of low dose monteplase and nicorandil before percutaneous coronary intervention in patients of acute myocardial infarction(SALMAN study).
Scientific Title
Evaluating safety and efficacy of low dose monteplase and nicorandil injected before percutaneous coronary intervention on left ventricular wall motion in patients of acute myocardial infarction:a randomized study.
Scientific Title:Acronym
Injection of low dose monteplase and nicorandil before percutaneous coronary intervention in patients of acute myocardial infarction(SALMAN study).
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of injection of low dose monteplase and nicorandil before percutaneous coronary intervention on left ventricular wall motion in patient of acute myocardial infarction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Left ventricular wall motion,event of heart failure,death and re-infarction,bleeding complication,time to recanalization,angiographical data,serum CPK and CKMB
Key secondary outcomes
Restenosis of infarcted artery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Both Monteplase,15000u per kg,and Nicorandil,4mg bolus injection and 96mg per day continuous injection,are injected.
Interventions/Control_2
Monteplase but no Nicorandil are injected
Interventions/Control_3
Nicorandil but no Monteplase are injected
Interventions/Control_4
Neither Monteplase nor Nicorandil are injected
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Acute myocardial infarction within 12 hours from onset.
Key exclusion criteria
Severe hepatic or renal dysfunction,anemia,restricted to use Monteplase or Nicorandil and to treat by PCI.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwao Ishibashi |
Organization
Chiba Emergency Medical Center
Division name
Division of Cardiology
Zip code
Address
3-32-1, Isobe, Mihama-ku, Chiba city, Chiba, Japan
TEL
043-279-2211
rocky12qq@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwao Ishibashi |
Organization
Chiba Emergency Medical Center
Division name
Division of Cardiology
Zip code
Address
3-32-1, Isobe, Mihama-ku, Chiba city, Chiba, Japan
TEL
043-279-2211
Homepage URL
rocky12qq@aol.com
Sponsor or person
Institute
Chiba Emergency Medical Center
Institute
Department
Personal name
Funding Source
Organization
Chiba Emergency Medical Center
Organization
Division
Category of Funding Organization
Self funding
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 | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 1999 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1999 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2001 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2002 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2002 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2005 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2016 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000294
