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

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 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


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

Value
https://center6.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