UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001729 |
|---|---|
| Receipt number | 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 15:03:43 |
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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
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
Sponsor or person
Institute
CHIBAKEN SAISEIKAI NARASINO HOSPITAL
internal medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002070
