UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000454 |
|---|---|
| Receipt number | R000000552 |
| Scientific Title | A study on preventive effect of cilostazol against deterioration of symptoms in acute stage of lacunar infarctions |
| Date of disclosure of the study information | 2006/08/01 |
| Last modified on | 2014/10/08 17:03:35 |
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Basic information
Public title
A study on preventive effect of cilostazol against deterioration of symptoms in acute stage of lacunar infarctions
Acronym
A study on efficacy for cilostazol for acute stage of lacunar infarctions
Scientific Title
A study on preventive effect of cilostazol against deterioration of symptoms in acute stage of lacunar infarctions
Scientific Title:Acronym
A study on efficacy for cilostazol for acute stage of lacunar infarctions
Region
| Japan |
Condition
Condition
ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether cilostazol prevent worsening of symptoms in acute stage of lacunar infarctions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Activity of Daily Living of 14days after onset which is assessed by modified Rankin Scale and Barthel Index
Key secondary outcomes
NIHSS: 7 and 14days after the admission
JSS: 7 and 14days after the admission
JSS-M: 7 and 14days after the admission
Barthel Index: 7 and 14days after the admission
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
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administered aspirin of 200mg orally for 14days
Interventions/Control_2
administered aspirin of 200mg and cilostazol of 200mg orally for 14days.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients admitted within 48hours from onset of lacunar infarction
modified Rankin Scale less than grade 4 on admission
Key exclusion criteria
patients with active bleeding or bleeding tendency
chronic heart falure
peptic ulcer
anemia
leukocytopenia
thrombocytopenia
liver dysfunction
renal dysfunction
neoplastic disorders
allergy to aspirin or cilostazol
asthma caused by aspirin
patients taking antiplatelet drugs, anticoagulants or NSAIDS
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terayama |
Organization
Iwate Medical University
Division name
Department of Neurology
Zip code
Address
19-1 Uchimaru, Morioka, Iwate, Japan
TEL
019-651-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Ishibashi |
Organization
Iwate Medical University
Division name
Department of Neurology
Zip code
Address
19-1 Uchimaru, Morioka, Iwate, Japan
TEL
019-651-5111
Homepage URL
yasubasi@iwate-med.ac.jp
Sponsor or person
Institute
Department of Neurology,Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2006 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 07 | Month | 25 | Day |
Last modified on
| 2014 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000552
