UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Department of Cardiovascular Medicine Saitama Medical University International Medical Center
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000427

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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