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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000229
Receipt No. 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

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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
Email 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
Email rocky12qq@aol.com

Sponsor
Institute Chiba Emergency Medical Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000294

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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