UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004373 |
|---|---|
| Receipt number | R000005226 |
| Scientific Title | Effect of Cilostazol on platelet activation in pateints with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2010/10/13 |
| Last modified on | 2013/07/09 16:03:11 |
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Basic information
Public title
Effect of Cilostazol on platelet activation in pateints with type 2 diabetes mellitus
Acronym
Effect of Cilostazol on platelet activation in pateints with type 2 diabetes mellitus
Scientific Title
Effect of Cilostazol on platelet activation in pateints with type 2 diabetes mellitus
Scientific Title:Acronym
Effect of Cilostazol on platelet activation in pateints with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have reported that the early platelet activation assessed by the spontaneous formation of platelet micro-aggregation was frequently occurred even in patients with type 2 diabetes mellitus who take aspirin, suggesting that the inhibitory effect of aspirin on early platelet activation may be insufficient. Thus, the aim of this study is to investigate whether Cilostazol, instead of aspirin, prevents the spontaneous formation of platelet micro-aggregation and inhibits the expression levels of active GPIIb/IIIa and P-selectin on platelets in type 2 diabetic patients who took aspirin and showed the spontaneous formation of platelet micro-aggregation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) the formation of spontaneous maicro-aggregation of platelet (SMAP)
2) the expression levels of active GPIIb/IIIa and P-selectin on the platelet
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The medication for the anti-platelet therapy in participants is changed from aspirin to cilostazol (200mg per day) and they continue this medication for 2 months.
Interventions/Control_2
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
type 2 diabetic patients who took aspirin and showed the formation of spontaneous micro-aggregation of platelets (SMAP)
Key exclusion criteria
1) diabetic patients except type 2 diabetes
2) patients below 20 years of age
3) pregnant pateints or the lactation period
4) complicated with malignacy, liver disease and collagen disease
5) taking any NSAIDs within 2 weeks
6) past history of bleeding within 6 weeks or bleeding tendency
7) complicated with sever coronary stenosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Maegawa |
Organization
Shiga University of Medical Science
Division name
Internal medicine
Zip code
Address
Seta, Otsu, Shiga, Japan
TEL
077-548-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Araki |
Organization
Shiga University of Medical Science
Division name
Internal medicine
Zip code
Address
Seta, Otsu, Shiga, Japan
TEL
077-548-2222
Homepage URL
araki@belle.shiga-med.ac.jp
Sponsor or person
Institute
Internal medicine, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Mitsui Life Social Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Clinical Pathological Biochemistry, Doshisha Women's Collage Liberal Arts
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
滋賀医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://care.diabetesjournals.org/content/36/7/e92.long
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
| 2009 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 18 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 12 | Day |
Last modified on
| 2013 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005226
| 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 |
