UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000699 |
|---|---|
| Receipt number | R000000836 |
| Scientific Title | Pioglitazone in Acute Ischemic Stroke Trial |
| Date of disclosure of the study information | 2008/12/31 |
| Last modified on | 2009/09/07 08:33:22 |
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Basic information
Public title
Pioglitazone in Acute Ischemic Stroke Trial
Acronym
Pioglitazone in Acute Ischemic Stroke Trial (PAIST)
Scientific Title
Pioglitazone in Acute Ischemic Stroke Trial
Scientific Title:Acronym
Pioglitazone in Acute Ischemic Stroke Trial (PAIST)
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether administration of pioglitazone provides a clinical benefit of patients with acute phase ischemic stroke
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
NIH stroke scale score at 3 months
Key secondary outcomes
Recurrence of stroke and Cardiovascular event (cerebral hemorrhage, subarachnoid hemorrhage, myocardial infarction, angina pectoris, and ASO) within 3 months after starting treatment
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be randomly selected to receive pioglitazone
Interventions/Control_2
Patients will also be randomly selected to receive treatment with conventional therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Admission within 7 days after the onset of ischemic stroke
2.Diabetes mellitus
3.cerebral thrombosis
4.NIHSS score 4-15
Key exclusion criteria
1.cardiogenic embolism or cerebral hemorrhage
2.pregnancy
3.allergic to pioglitazone
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 165-8582 Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Hoshino |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 165-8582 Japan
TEL
03-3353-1211
Homepage URL
hhoshino-keio@umin.ac.jp
Sponsor or person
Institute
Keio University School of Medicine Department of Neurology
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
Department of Neurology, Tokyo Saiseikai Central Hospital
Name of secondary funder(s)
None
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
| 2008 | Year | 12 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 05 | Month | 01 | Day |
Last modified on
| 2009 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000836
