UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002681 |
|---|---|
| Receipt number | 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 01:02:34 |
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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
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
jsatomi@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Neurosurgery, Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003266
