UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000344 |
|---|---|
| Receipt number | 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 15:27:49 |
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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
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
komiyama@saitama-med.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
