NCT00482183

Comparison Between Pioglitazone and SES With type2 DM

Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Showa University · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones effectively reduced restenosis and the risk of repeat target vessel revascularization. We conducted a study to compare the performance of a drug-eluting stent with that of a bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.

Detailed description

The study is a prospective cohort trial involving 38 type 2 diabetic patients referred for coronary stenting who were assigned to either the sirolimus-eluting stent group or the pioglitazone group. Quantitative coronary angiography will be performed at study entry and at six months follow-up to evaluate in-stent late luminal loss and the percentage of the luminal diameter and the rate of restenosis. We also analyze major adverse cardiac events at 12 months.

Conditions

• Coronary Artery Disease
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Pioglitazone

Timeline

• Start date: 2003-07-01
• Completion: 2007-06-01
• First posted: 2007-06-05
• Last updated: 2007-06-05