UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004950 |
|---|---|
| Receipt number | R000005888 |
| Scientific Title | Acute aspirin plus cilostazol Dual Therapy for non-cardioembolic stroke patients within 48 h of symptom onset -a prospective, multicenter, randomized, an aspirin-controlled study- |
| Date of disclosure of the study information | 2011/06/02 |
| Last modified on | 2014/10/23 12:10:41 |
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Basic information
Public title
Acute aspirin plus cilostazol Dual Therapy for non-cardioembolic stroke patients within 48 h of symptom onset -a prospective, multicenter, randomized, an aspirin-controlled study-
Acronym
Acute aspirin plus cilostazol Dual Therapy for non-cardioembolis stroke
Scientific Title
Acute aspirin plus cilostazol Dual Therapy for non-cardioembolic stroke patients within 48 h of symptom onset -a prospective, multicenter, randomized, an aspirin-controlled study-
Scientific Title:Acronym
Acute aspirin plus cilostazol Dual Therapy for non-cardioembolis stroke
Region
| Japan |
Condition
Condition
Non cardioembolic stroke
Classification by specialty
| Neurology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of antiplatelet(aspirin plus cilostazol) dual therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Rakin scale score at 3 months after stroke
neurological worsening within 14 days of stroke onset
TIA, stroke reccurence, intracerebral hemorrhage, subarachnoid hemorrhage within 14 days of stroke onset
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
From May 2011 to April 2013
aspirin plus cilostazol group
aspirin 81-200mg plus cilostazol 200mg
Interventions/Control_2
From May 2011 to April 2013
aspirin group
aspirin 81-200mg
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
non-cardioembolic stroke within 48 hours of onset
NIHSS score on admission 20 points or over
preadmission mRS score 0-2
Key exclusion criteria
cardioembolic stroke
preadmission antithrombotic therapy (cilostazol, aspirin 200mg or over, clopidgrel, ticlopidine, anticoagulants)
congestive heart failure
pregnancy
allergy
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Inoue |
Organization
Kawasaki Medical School
Division name
Stroke Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
inouet@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Inoue |
Organization
Kawasaki Medical School
Division name
Stroke Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
inouet@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Stroke Medicine Kawasaki Medical School
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
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
| 2011 | Year | 06 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2014 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005888
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
