Comparison Between Pioglitazone and SES With type2 DM

Showa University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Artery Disease; Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00482183

CCT-NAPN-16586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)