UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000485 |
|---|---|
| Receipt number | R000000588 |
| Scientific Title | Prevention of in-stent neointimal proliferation by Pioglitazone Study |
| Date of disclosure of the study information | 2006/09/13 |
| Last modified on | 2008/03/26 21:54:32 |
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Basic information
Public title
Prevention of in-stent neointimal proliferation by Pioglitazone Study
Acronym
POPPS
Scientific Title
Prevention of in-stent neointimal proliferation by Pioglitazone Study
Scientific Title:Acronym
POPPS
Region
| Japan |
Condition
Condition
Type 2 diabetic patients with ischemic heart disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of pioglitazone in preventing restenosis after stent implantation in ischemic heart disease patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Angiographical restenosis and target lesion revascularization at 6 months follow-up
Key secondary outcomes
Neointimal volume assessed by intravascular ultrasound at 6months follow-up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group: Patients are randomely asseigned to either control or Pioglitazone group. Control group can be treated with any medication except for Pioglitazone.
Interventions/Control_2
Intervention group: Patients are randomely asseigned to either control or intervention (Pioglitazone) group. Intervention group are treated with Pioglitazone (15-30mg).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stable angina pectoris or acute coronary syndrome (unstabel angina pectoris or acute myocardial infarction) with type 2 diabetes mellitus diagnosed by the following criteria.
(1). FBS >= 126mg/dl
(2). Glucose level 2 hours after 75g OGTT >= 200mg/dl
(3). Known history of diabetes mellitus
Key exclusion criteria
(1).Severe liver or renal insufficiency(2).TIMI-flow grade <= 2
(3).Cardiogenic shock or congestive heart failure
(4).Contraindication to antiplatelet therapy
(5).Patient with gastrointestinal bleeding or transient ischemic attack
(6).Ineligible for CABG
(7). Ineligible for percutaneous coronary intervention
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okura |
Organization
Kawasaki Medical School
Division name
Division of Cardiology
Zip code
Address
577 Matsushima, Kutrashiki-city, Okayama 701-0192, JAPAN
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okura |
Organization
Kawasaki Medical School
Division name
Division of Cardiology
Zip code
Address
577 Matsushima, Kutrashiki-city, Okayama 701-0192, JAPAN
TEL
086-462-1111
Homepage URL
hokura@fides.dti.ne.jp
Sponsor or person
Institute
Bell Land General Hospital
Institute
Department
Personal name
Funding Source
Organization
Oska City University Medical School, Division of Cardiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Bell Land General Hospital
Kobe General Hospital
Osaka City General Hospital
Osaka City University Medical School
Fuchu Hospital
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
| 2006 | Year | 09 | Month | 13 | 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
| 2003 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 09 | Month | 12 | Day |
Last modified on
| 2008 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000588
| Research Plan | |
|---|---|
| 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 |
