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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000485
Receipt No. 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

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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
Email

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
Email hokura@fides.dti.ne.jp

Sponsor
Institute Bell Land General Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000588

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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