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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000344
Receipt No. R000000430
Scientific Title Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Acute Coronary Syndrome.
Date of disclosure of the study information 2006/03/03
Last modified on 2014/03/02

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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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