UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006931 |
|---|---|
| Receipt number | R000008193 |
| Scientific Title | The efficacy and safety of the antiplatelet therapy in acute non-cardiogenic ischemic stroke. |
| Date of disclosure of the study information | 2011/12/22 |
| Last modified on | 2015/08/03 16:45:02 |
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Basic information
Public title
The efficacy and safety of the antiplatelet therapy in acute non-cardiogenic ischemic stroke.
Acronym
The efficacy and safety of the antiplatelet therapy in acute non-cardiogenic ischemic stroke.
Scientific Title
The efficacy and safety of the antiplatelet therapy in acute non-cardiogenic ischemic stroke.
Scientific Title:Acronym
The efficacy and safety of the antiplatelet therapy in acute non-cardiogenic ischemic stroke.
Region
| Japan |
Condition
Condition
Non-cardiogenic ischemic stroke in acute phase.
Classification by specialty
| Neurology | Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the efficacy and the safety of starting administration of cilostazol and aspirin in the acute phase of non-cardiogenic ischemic stroke within 24 hours from the onset.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The percentage of patients with mRS 0 to 3 at 3 months.
Key secondary outcomes
1) The frequency of progressive stroke on day 2 and7.
2) The frequency of stroke and myocardial infarction.
3) The frequency of hemorrhagic event.
4) The frequency of adverse event.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aspirin and cilostazol group
Aspirin (100mg/day) and cilostazol (200mg/day) are administered for 3months.
Interventions/Control_2
Aspirin group
Aspirin (100mg/day) is administered for 3months.
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) The diagnosis of ischemic stroke was based on neurological examination and computed tomography or magnetic resonance imaging.
2) Being able to taking drugs orally.
3) An age of 20 years or older, with written informed consent.
Key exclusion criteria
1) Having aphasia or mental retardation.
2) Having serious liver dysfunction, renal dysfunction, angina, myocardial infarction.
3) Having hemorrhagic disease.
4) Having tachyarrhythmia to need treatment.
5) A patient with suspected cardiogenic cerebral infarction.
6) Contraindication for cilostazol, aspirin, ozagrel, and edaravon.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Matsumura |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurosurgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3220
neuros-saito@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunobu Nakai |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurosurgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3220
Homepage URL
y-nakai@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Budget grant
Organization
Division
Category of Funding Organization
Self funding
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
筑波大学附属病院（茨城県）、茨城西南医療センター病院（茨城県）、筑波メディカルセンター病院（茨城県）、筑波記念病院（茨城県）、総合守谷第一病院（茨城県）、県南病院（茨城県）、小張総合病院（千葉県）、茨城県立中央病院（茨城県）、国立病院機構水戸医療センター（茨城県）、水戸済生会病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 22 | 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
| 2011 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 21 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008193
