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 |
Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Acute Coronary Syndrome.
PIGEON-ACS
Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Acute Coronary Syndrome.
PIGEON-ACS
Japan |
Acute coronary syndrome
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
To evaluate whether pioglitazone clinically alters structure of coronary atherosclerotic plaques in patients with acute coronary syndrome.
Pharmacodynamics
Confirmatory
Explanatory
Phase II,III
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
Death, Acute myocardial infarction, Onset of angina whose culprit lesion is subjective coronary plaque, Severe heart failure
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Pioglitazone 30mg/day
Fluvastatin 20mg/day
Fluvastatin 20mg/day
Not applicable |
80 | years-old | > |
Male and Female
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
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.
100
1st name | |
Middle name | |
Last name | Nobuyuki Komiyama |
Saitama Medical University International Medical Center
Division of Cardiology
1397-1 Yamane Hidaka-Shi Saitama-Pref
042-984-4111
komiyama@saitama-med.a.jp
1st name | |
Middle name | |
Last name | Nobuyuki Komiyama |
Saitama Medical University International Medical Center
Division of Cardiology
1397-1 Yamane Hidaka-Shi Saitama-Pref
042-984-4111
komiyama@saitama-med.ac.jp
Department of Cardiovascular Medicine
Saitama Medical University International Medical Center
Department of Cardiovascular Medicine
Saitama Medical University International Medical Center
Self funding
NO
埼玉医科大学国際医療センター(埼玉県)
2006 | Year | 03 | Month | 03 | Day |
Unpublished
Completed
2006 | Year | 02 | Month | 01 | Day |
2006 | Year | 04 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2012 | Year | 08 | Month | 31 | Day |
2006 | Year | 03 | Month | 02 | Day |
2014 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000430