Comparison Between Pioglitazone and SES With type2 DM

Phase 2

Completed

• Conditions: Coronary Artery Disease; Type 2 Diabetes Mellitus

• Registration Number: NCT00482183
• Lead Sponsor: Showa University

Brief 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.

Study Timeline

• Study Start: 2003-07
• Status Verified: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Last Update Submitted: 2007-06-04
• Study First Posted: 2007-06-05
• Last Update Posted: 2007-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study.

Exclusion Criteria

• spastic angina pectoris
• congestive heart failure
• hepatic dysfunction
• chronic renal disease
• recent stroke
• impaired glucose tolerance
• insulin dependent diabetes mellitus
• familial hypercholesterolemia
• thyroid dysfunction
• adrenal dysfunction
• an intolerance of aspirin, ticlopidine, heparin, pioglitazone, stainless steel, or contrast material.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.	Within 12minths after the procedure

Secondary Outcome Measures

Name	Time	Method
Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.	6 months after procedure