UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005687 |
|---|---|
| Receipt number | R000006721 |
| Scientific Title | Liraglutide reduce infarction size in a acute myocardiac infarction patients with Diabetes mellitus |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/05/31 16:20:48 |
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Basic information
Public title
Liraglutide reduce infarction size in a acute myocardiac infarction patients with Diabetes mellitus
Acronym
LISA Trial
Scientific Title
Liraglutide reduce infarction size in a acute myocardiac infarction patients with Diabetes mellitus
Scientific Title:Acronym
LISA Trial
Region
| Japan |
Condition
Condition
Diabetes mellitus
acute myocardiac infarction
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In acute myocardial infarction patient complicated with diabetes, I examine it against control about an effect on reduction of the myocardial infarction size of Liraglutide
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement degree of cardiac function expressed in EF(Teichholz method , Simpson method) and EDV at start of therapy, one week later, the time of a discharge, six months later
Key secondary outcomes
1. Change of the following item
RBC, WBC, Hb, Ht, Plt, TC, LDL-C, TG, HDL-C, ALT, AST, ganma-GTP, CK, CK-MB, BUN, Cr, BS, HbA1c, 1,5-AG, BNP
2. Coronary angiography (QCA:Quantitative Coronary Analysis) at the time of start of therapy, before a discharge, six months later .
3.Improvement degree of cardiac function expressed by MRI
4.major adverse cardiac events
5.Hypoglycemia event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Liraglutide
Interventions/Control_2
Placebo
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
he case that was treated for myocardial infarction to assume the left coronary arteries
Diabetes which have already received a diabetes drugs or the person which became the diagnosis of diabetes during hospitalization
The person who does not receive GLP-1 analog and the DPP-IV inhibitor so far
Key exclusion criteria
Case having a serious renal damage and liver damage(Cr>2.0mg/dl, T-Bil>3.0mg/dl, PT<60%, Alb<2.8mg/dl)
CABG enforcement planned case
Case within CABG enforcement three months
Case contraindicated to the dosage of Liraflutide
The case that is using insulin
Case having a serious underlying disease (including a malignant tumor, an infectious disease, DIC)
The case that infarction responsibility blood vessel is a bypass graft
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Sakai |
Organization
Shin-Tokyo hospital
Division name
Endocrinolory and diabetes internal medicine
Zip code
Address
473-1 nemoto, matsudo city, Chiba, Japan
TEL
+81-47-366-7000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | koji sakai |
Organization
Shin-Tokyo hospital
Division name
Endocrinolory and diabetes internal medicine
Zip code
Address
473-1 nemoto, matsudo city, Chiba, Japan
TEL
+81-47-366-7000
Homepage URL
kojisakai@sc4.so-net.ne.jp
Sponsor or person
Institute
Shin-Tokyo hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
YES
Study ID_1
0021-1
Org. issuing International ID_1
Shin-Tokyo hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新東京病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 31 | Day |
Last modified on
| 2011 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006721
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
