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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001729
Receipt No. R000002070
Scientific Title Prevention and regression of carotid artery IMT with Cilostazol and Pioglitazone use in atherosclerosis with type 2 diabetes
Date of disclosure of the study information 2009/03/01
Last modified on 2009/02/19

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Basic information
Public title Prevention and regression of carotid artery IMT with Cilostazol and Pioglitazone use in atherosclerosis with type 2 diabetes
Acronym PRECIOUS
Scientific Title Prevention and regression of carotid artery IMT with Cilostazol and Pioglitazone use in atherosclerosis with type 2 diabetes
Scientific Title:Acronym PRECIOUS
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of concomitant use of cilostazol and pioglitazone on prevention and regression of carotid IMT in patients with type 2 DM
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Absolute change of carotid Max-IMT
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A
Follow up 2-year prospective follow-up study
Dose Cilostazol 100-200mg/day, Pioglitazone 15-30 mg/day, Aspirin 100-300 mg/day
Measure IMT; After 0,6,12,24 Month
Interventions/Control_2 Group B
Follow up 2-year prospective follow-up srudy
Dose; Pioglitazone 15-30 mg/day, Aspirin 100-300 mg/day
Measure IMT After 0,6,12,24 Month
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Type 2 diabetes mellitus
2. Pts receiving pioglitazone therapy for at least 6 months
3. Pts receiving aspirin therapy
4. Age between 50 to 80 years
5. Either outpatient or inpatient
Key exclusion criteria 1. HbA1c and over 10%
2. Medical history or presumptive of carotid arterial reconstruction
3. BNP and over 100
4. Early stage of stroke
5. Arterial fibrillation
6. Under anti-platelet therapy other than aspirin
7. Receiving warfarin-potassium therapy
8. Congestive heart failure
9. Severe hepatic disfunction or renal disfunction
10. Severe infections disease, injury, pre or post operation
11. Severe ketosis, diabetic coma, type 1 diabetes mellitus
12. Pts who are bleeding
13. Drug allergies or medical history of hypersensitivity to the investigational drugs
14. Pregnant or lactating women, or women who wish to become pregnant
15. Others whom the investigator judges inappropriate as subjects for this study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimasa Fujiwara
Organization CHIBAKEN SAISEIKAI NARASINO HOSPITAL
Division name internal medicine
Zip code
Address 1-1-1, Izumi, Narashino-shi, Chiba,
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshimasa Fujiwara
Organization CHIBAKEN SAISEIKAI NARASINO HOSPITAL
Division name internal medicine
Zip code
Address
TEL 047-473-1281
Homepage URL
Email

Sponsor
Institute CHIBAKEN SAISEIKAI NARASINO HOSPITAL
internal medicine
Institute
Department

Funding Source
Organization FAIS
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 03 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
Date of protocol fixation
2008 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 23 Day
Last modified on
2009 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002070

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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