UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000332 |
|---|---|
| Receipt number | R000000427 |
| Scientific Title | Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Metabolic Syndrome. |
| Date of disclosure of the study information | 2006/03/03 |
| Last modified on | 2012/08/17 10:06:08 |
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Basic information
Public title
Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Metabolic Syndrome.
Acronym
PIGEON-MS
Scientific Title
Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Metabolic Syndrome.
Scientific Title:Acronym
PIGEON-MS
Region
| Japan |
Condition
Condition
Coronary atherosclerosis
Metabolic syndrome
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate wheather pioglitazone alters the structure of coronary atherosclerotic plaque in patients with metabolic syndrome.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Change in volume of coronary atherosclerotic plaque evaluated by intravascular ultrasound
Change in tissue components of coronary atherosclerotic plaque evaluated by intravascular ultrasound
Change in plasma lipid profile
Change in inflammatory markers
Key secondary outcomes
Death, Acute coronary syndrome, Newly onset of angina whose culprit lesion is subjective plaque, Severe heart failure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Piogllitazone 30mg/day
Interventions/Control_2
Valsartan 40-80mg/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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Candidate for percutaneous coronary intervention
LVEF > 40%
Metabolic syndrome ()
Key exclusion criteria
Acute coronary syndrome (acute myocardial infarction / unstable angina)
Undergo insulin therapy
Severe liver dysfunction, severe renal dysfunction
Undergo treatment of heart failure
Already taking pioglitazone
History of side effect of thiazolidines
CD36 defficiency
Pregnancy or possible pregnancy
Non-hypertension
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Komiyama |
Organization
Saitama Medical University International Medical Center
Division name
Cardiology
Zip code
Address
1397-1 Yamane Hidaka-Shi Saitama-Pref
TEL
042-984-4111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Komiyama |
Organization
Saitama Medical University International Medical Center
Division name
Cardiology
Zip code
Address
1397-1 Yamane Hidaka-Shi Saitama-Pref
TEL
042-984-4111
Homepage URL
Sponsor or person
Institute
Department of Cardiovascular Medicine
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine
Saitama Medical University International Medical Center
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
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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 2005 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 02 | Month | 17 | Day |
Last modified on
| 2012 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000427
