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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name