UMIN ID: UMIN000000899
Registered date:19/11/2007
Improvement effects of pioglitazone on endothelial function after sirolimus-eluting stent (Cypher stent) implantation: a randomized, open rabelled, prospective study.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | coronary artery disease |
Date of first enrollment | 2007/04/01 |
Target sample size | 50 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Intervention group: Start to take pioglitazone 15mg per day after percutaneous coronary angioplasty and increase a dose to 30mg per day at 14days after angioplasty. And continue in 9 months. Control group: Take no pioglitazone in 9 months after percutaneous coronary angioplasty. |
Outcome(s)
Primary Outcome | Coronary endothelial function with acetylcholine by quantitative coronary angiography. Plasma glucose, HbA1C, total cholesterol, triglyceride, LDL, HDL, MDA-LDL, HMW-adiponectin and hs-CRP. Major adverse cardiovascular event and harmful effect of pioglitazone. |
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Secondary Outcome | Plasma GOT, GPT, T-BIL, ALP, LDH, CPK and BNP |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 85years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | Acute myocardial infarction, heart failure, severe hepatic or renal dysfunction, already to take pioglitazone, pregnancy and in-stent restenotic lesion. |
Related Information
Primary Sponsor | Chiba University Graduate School of Medicine |
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Secondary Sponsor | |
Source(s) of Monetary Support | none |
Secondary ID(s) |
Contact
public contact | |
Name | Hideki Kitahara |
Address | Japan |
Telephone | 043-222-7171 |
Affiliation | Chiba University Graduate School of Medicine Division of cardiovascular science and medicine |
scientific contact | |
Name | Issei Komuro |
Address | 1-8-1 Inohana, Chu-o ku, Chiba city, Chiba, JAPAN Japan |
Telephone | 043-222-7171 |
Affiliation | Chiba University Graduate School of Medicine Division of cardiovascular science and medicine |