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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Acute coronary syndrome | |||
Classification by specialty |
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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 |
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Interventions/Control_1 | Pioglitazone 30mg/day
Fluvastatin 20mg/day |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |