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

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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&#8804;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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name