![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000332 |
Receipt No. | R000000427 |
Scientific Title | Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Metabolic Syndrome. |
Date of disclosure of the study information | 2006/03/03 |
Last modified on | 2012/08/17 |
Basic information | ||
Public title | Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Metabolic Syndrome. | |
Acronym | PIGEON-MS | |
Scientific Title | Pioglitazone Intervention for Coronary Atherosclerosis in Patients with Metabolic Syndrome. | |
Scientific Title:Acronym | PIGEON-MS | |
Region |
|
Condition | |||
Condition | Coronary atherosclerosis
Metabolic syndrome |
||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate wheather pioglitazone alters the structure of coronary atherosclerotic plaque in patients with metabolic 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 volume of coronary atherosclerotic plaque evaluated by intravascular ultrasound
Change in tissue components of coronary atherosclerotic plaque evaluated by intravascular ultrasound Change in plasma lipid profile Change in inflammatory markers |
Key secondary outcomes | Death, Acute coronary syndrome, Newly onset of angina whose culprit lesion is subjective 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 |
|
|
Interventions/Control_1 | Piogllitazone 30mg/day | |
Interventions/Control_2 | Valsartan 40-80mg/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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Candidate for percutaneous coronary intervention
LVEF > 40% Metabolic syndrome () |
|||
Key exclusion criteria | Acute coronary syndrome (acute myocardial infarction / unstable angina)
Undergo insulin therapy Severe liver dysfunction, severe renal dysfunction Undergo treatment of heart failure Already taking pioglitazone History of side effect of thiazolidines CD36 defficiency Pregnancy or possible pregnancy Non-hypertension |
|||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Saitama Medical University International Medical Center | ||||||
Division name | Cardiology | ||||||
Zip code | |||||||
Address | 1397-1 Yamane Hidaka-Shi Saitama-Pref | ||||||
TEL | 042-984-4111 | ||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Saitama Medical University International Medical Center | ||||||
Division name | Cardiology | ||||||
Zip code | |||||||
Address | 1397-1 Yamane Hidaka-Shi Saitama-Pref | ||||||
TEL | 042-984-4111 | ||||||
Homepage URL | |||||||
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 | Japan |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000427 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |