UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000537 |
|---|---|
| Receipt number | R000000654 |
| Scientific Title | Effects of anti-platelet drugs on circulating endotheial progenitor cells and oxidative stress in diabetic patients with ischemic cerebrovascular diseases |
| Date of disclosure of the study information | 2006/12/05 |
| Last modified on | 2010/04/05 16:09:30 |
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Basic information
Public title
Effects of anti-platelet drugs on circulating endotheial progenitor cells and oxidative stress in diabetic patients with ischemic cerebrovascular diseases
Acronym
Effects of cilostazol on circulating EPC and oxidative stress
Scientific Title
Effects of anti-platelet drugs on circulating endotheial progenitor cells and oxidative stress in diabetic patients with ischemic cerebrovascular diseases
Scientific Title:Acronym
Effects of cilostazol on circulating EPC and oxidative stress
Region
| Japan |
Condition
Condition
diabetic patients with ischemic cerevrobascular diseases
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the underlying mechanisms of cilostazol-mediated protection of ischemic stroke, the effect of cilostazol (200mg/day) on circulating endothelial progenitor cells (EPC) and markers of oxidative stress is examined in diabetic patients with ischemic cerebrovascular diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
circulating endothelial progenitor cells, markers of oxidative stress
Key secondary outcomes
cerevrovascular events, the extent of lacuna stroke
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
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cilostazol 200 mg/day
Interventions/Control_2
aspirin 100 mg/day
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) diabetic subjects
2) patients with ischemic cerebrovascular diseases diagnosed with magnetic resonance imaging
3) patietns who agreed to participate with written informed consent
4) patietns is or older than 20-years old when agreed to participate
Key exclusion criteria
1) patients who is treated with cilostazol
2) patients who suffers from bleeding disorders
3) patients with unstable congestive heart failure or angina pectoris
4) patients with allergy against cilostazol
5) pqtients with allergy against aspirin
6) patients with cardiac diseases associated with cereberal embolism
7) patients with malignant diseases or hard to be followed
8) patients who are judged to be inappropriate for inclusion
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Koyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545
TEL
06-6645-3806
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Koyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545
TEL
06-6645-3806
Homepage URL
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 05 | Day |
Last modified on
| 2010 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000654
| Research Plan | |
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| 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 |
