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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000899
Receipt No. R000001081
Scientific Title Improvement effects of pioglitazone on endothelial function after sirolimus-eluting stent (Cypher stent) implantation: a randomized, open rabelled, prospective study.
Date of disclosure of the study information 2007/11/19
Last modified on 2011/03/10

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Basic information
Public title Improvement effects of pioglitazone on endothelial function after sirolimus-eluting stent (Cypher stent) implantation: a randomized, open rabelled, prospective study.
Acronym Improvement effects of pioglitazone on endothelial function after Cypher stent implantation: a randomized study.
Scientific Title Improvement effects of pioglitazone on endothelial function after sirolimus-eluting stent (Cypher stent) implantation: a randomized, open rabelled, prospective study.
Scientific Title:Acronym Improvement effects of pioglitazone on endothelial function after Cypher stent implantation: a randomized study.
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Pioglitazone for endothelial function after sirolimus-eluting stent (Cypher stent) implantation for non-diabetic patient with coronary artery disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Coronary endothelial function with acetylcholine by quantitative coronary angiography.
Plasma glucose, HbA1C, total cholesterol, triglyceride, LDL, HDL, MDA-LDL, HMW-adiponectin and hs-CRP.
Major adverse cardiovascular event and harmful effect of pioglitazone.
Key secondary outcomes Plasma GOT, GPT, T-BIL, ALP, LDH, CPK and BNP

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention group: Start to take pioglitazone 15mg per day after percutaneous coronary angioplasty and increase a dose to 30mg per day at 14days after angioplasty. And continue in 9 months.
Interventions/Control_2 Control group: Take no pioglitazone in 9 months after percutaneous coronary angioplasty.
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
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patient who don't have type 2 diabetes mellitus with undergoing percutaneous coronary angioplasty.
Key exclusion criteria Acute myocardial infarction, heart failure, severe hepatic or renal dysfunction, already to take pioglitazone, pregnancy and in-stent restenotic lesion.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Issei Komuro
Organization Chiba University Graduate School of Medicine
Division name Division of cardiovascular science and medicine
Zip code
Address 1-8-1 Inohana, Chu-o ku, Chiba city, Chiba, JAPAN
TEL 043-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Kitahara
Organization Chiba University Graduate School of Medicine
Division name Division of cardiovascular science and medicine
Zip code
Address
TEL 043-222-7171
Homepage URL
Email

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2007 Year 11 Month 19 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
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2010 Year 04 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
2007 Year 11 Month 19 Day
Last modified on
2011 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001081

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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