UMIN-CTR Clinical Trial

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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