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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004373
Receipt No. 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

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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
Email

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
Email araki@belle.shiga-med.ac.jp

Sponsor
Institute Internal medicine, Shiga University of Medical Science
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005226

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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