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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000537
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000654

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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