Improvement effects of pioglitazone on endothelial function after sirolimus-eluting stent (Cypher stent) implantation: a randomized, open rabelled, prospective study.

UMIN ID: UMIN000000899

Registered date:19/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• 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.
• Secondary Outcome: Plasma GOT, GPT, T-BIL, ALP, LDH, CPK and BNP

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• 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
• Source(s) of Monetary Support: none