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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000673
Receipt No. R000000809
Scientific Title Cilostazol in Acute Ischemic Stroke Trial
Date of disclosure of the study information 2008/12/31
Last modified on 2011/10/04

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Basic information
Public title Cilostazol in Acute Ischemic Stroke Trial
Acronym Cilostazol in Acute Ischemic Stroke Trial (CAIST-J)
Scientific Title Cilostazol in Acute Ischemic Stroke Trial
Scientific Title:Acronym Cilostazol in Acute Ischemic Stroke Trial (CAIST-J)
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 cilostazol provides an 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 modified Rankin scale 0-2 at 3 month
Key secondary outcomes Recurrence of stroke, NIHSS, JSS, Barthel Indes, modified Rankin Scale, Zung, MMSE, Neurological deterioration, Pneumonia

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 cilostazol.
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 72 hours after the onset of ischemic stroke
2. NIHSS score 14>=
Key exclusion criteria 1.cardiogenic embolism
2.previous ischemic stroke episode within 6 months
3.hemorrhagic stroke
4.consciousness disturbance
5.prestroke modified Rankin Scale 2<=
6.malignancy
7.pregnancy
8.allergic to cilostazol
Target sample size 350

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
Institute Keio University School of Medicine Department of Neurology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokai University
Tokai University Hachioji Hospital
Saitama Medical Universitygy
Toyama University
Iwate Medical University
Juntendo University

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
2006 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 04 Month 06 Day
Last modified on
2011 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000809

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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