UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002681
Receipt No. R000003266
Scientific Title long term Effect of the antiplatelet therapy on ischemic stroke
Date of disclosure of the study information 2009/12/31
Last modified on 2010/11/26

* 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 long term Effect of the antiplatelet therapy on ischemic stroke
Acronym long term Effect of the antiplatelet therapy on ischemic stroke
Scientific Title long term Effect of the antiplatelet therapy on ischemic stroke
Scientific Title:Acronym long term Effect of the antiplatelet therapy on ischemic stroke
Region
Japan

Condition
Condition cerebral infarction except cardioembolic cerebral embolism
Classification by specialty
Neurology Neurosurgery Emergency medicine
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Long term effect of cilostasol, antiplatelet, against acute ischemic stroke except cardioembolism with seven days after onset will be assessed as compared with aspirin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes activity of daily life
improvement effect of the depression
Key secondary outcomes recurrence of the ischemic stroke
cardiovascular adverse event
hemorrhagic complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2 years after permission
cilostasol group:200mg a day oral intake
Interventions/Control_2 2 years after permission
aspirin group:100mg a dat oral intake
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. age between 20 and 89 years old
2. patients diagnosed as cerebral infarction by CT or MRI
3. newly diagnosed as cerebral infarction except cardioembolic stroke
4.National institute of Health stroke scale at initial assessment is below 20
5. possible intake of antiplatelet within 7 days after stroke onset
6.modified Rankin scale before stroke onset is below 3
7. patients can be monitored over 3 months
8.patients obtained informed consent
Key exclusion criteria 1. hemorrhage of hemorrhagic tendenncy
2. indicatied for fibrinokytis therapy using t-PA
3. unable to take antiplatelets
4. allergy for antiplatelets using in this study
5. conttraindicated for drugs using in this study
6. bed ridden state or no expectancy to improve activity of daily life
7. transient ischemic attack
8. other taking drugs are contraindicated to take with antiplatelets using in this study
9. patients enrolled in other clinical trial
10. patients who are assessed inappropriate to enroll in this study by doctors
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Nagahiro
Organization Tokushima University Hospital
Division name Neurosurgery
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima city, Japan
TEL 088-633-7149
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima University Hospital
Division name Neurosurgery
Zip code
Address
TEL
Homepage URL
Email jsatomi@clin.med.tokushima-u.ac.jp

Sponsor
Institute Neurosurgery, Tokushima University Hospital
Institute
Department

Funding Source
Organization Japan Foundation for Neuroscience and Mental Health
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2009 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 06 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 27 Day
Last modified on
2010 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.