UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013499 |
|---|---|
| Receipt number | R000015768 |
| Scientific Title | Juntendo the Stroke Prevention study in Insulin Resistance and Impaired glucose Tolerance (J-SPIRIT study) |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2014/03/24 18:40:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Juntendo the Stroke Prevention study in Insulin Resistance and Impaired glucose Tolerance (J-SPIRIT study)
Acronym
The efficacy of pioglitazone for secodary prevention of ischemic stroke
Scientific Title
Juntendo the Stroke Prevention study in Insulin Resistance and Impaired glucose Tolerance (J-SPIRIT study)
Scientific Title:Acronym
The efficacy of pioglitazone for secodary prevention of ischemic stroke
Region
| Japan |
Condition
Condition
symptomatic ischemic stroke or transient ischemic attacak (TIA)
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effeicacy of pioglitazone for secandary prevention in ischemic stroke patients with abnormal glucose metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence of ischemic stroke
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
with pioglitazone
Interventions/Control_2
without pioglitazone
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Symptomatic ischemic stroke or transient ischemic attack (TIA)
2. modified Ranking Scale≤3
3. The patients without the diagnosis of diabetes mellitus or without taking any anti diabetics, received 75g OGTT, and show any abnomral glucose metabolism such as IFG, or IGT, or diabetes mellitus
Key exclusion criteria
1. patinents with bleeding
2. patients with pregnant or its possibility
3. severe renal dysfunction or liver dysfunction
4. allergy against alogliptin
5. can not receive informed concent
6. inappropriate for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Urabe |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Neurology
Zip code
Address
2-1-1, Tomioka, Urayasu city, Chiba
TEL
047-353-3111
t_urabe@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Tanaka |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
r_tanaka@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部附属順天堂医院（東京都）、順天堂大学医学部附属浦安病院（千葉県）、順天堂大学医学部附属静岡病院（静岡県）、順天堂大学医学部附属東京都江東高齢者医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 24 | 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
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 24 | Day |
Last modified on
| 2014 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015768
