UMIN-CTR Clinical Trial

Basic information
Public title	Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Acute Coronary Syndrome.
Acronym	PIGEON-ACS
Scientific Title	Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Acute Coronary Syndrome.
Scientific Title:Acronym	PIGEON-ACS
Region	Japan

Condition
Condition	Acute coronary syndrome
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether pioglitazone clinically alters structure of coronary atherosclerotic plaques in patients with acute coronary 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 volumes of coronary atherosclerotic plaques evaluated by intravascular ultrasound Change in histological components of coronary atherosclerotic plaques evaluated by intravascular ultrasound Change in plasma lipid profile Change in plasma inflammatory markers
Key secondary outcomes	Death, Acute myocardial infarction, Onset of angina whose culprit lesion is subjective coronary 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	Pioglitazone 30mg/day Fluvastatin 20mg/day
Interventions/Control_2	Fluvastatin 20mg/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	Cases with ST elevation or Non-ST elevation myocardial infarction, or unstable angina who are candidate for emergent percutaneous coronary intervention. LVEF is equal to or more than 40% Written informed consent
Key exclusion criteria	LVEF < 40% Newly onset of congestive heart failure Treatment with insulin Type 1 diabetes Severe liver dysfunction, severe renal dysfunction Already treatment with pioglitazone History of side effects of thiazolidines CD36 defficiency Pregnancy or possible pregnancy A case whose attending physician decides he is not a candidate for the study by any reason.
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	Division of Cardiology
Zip code
Address	1397-1 Yamane Hidaka-Shi Saitama-Pref
TEL	042-984-4111
Email	komiyama@saitama-med.a.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuyuki Komiyama
Organization	Saitama Medical University International Medical Center
Division name	Division of Cardiology
Zip code
Address	1397-1 Yamane Hidaka-Shi Saitama-Pref
TEL	042-984-4111
Homepage URL
Email	komiyama@saitama-med.ac.jp

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

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（埼玉県）

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	2006 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2006 Year 04 Month 01 Day
Last follow-up date	2010 Year 10 Month 01 Day
Date of closure to data entry	2010 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded	2012 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2006 Year 03 Month 02 Day
Last modified on	2014 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000430

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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