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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00482183

Enrollment

Registered

2007-06-05

Start date

2003-07-31

Completion date

2007-06-30

Last updated

2007-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Type 2 Diabetes Mellitus

Keywords

Bare metal stent, Major adverse cardiac events, Pioglitazone, Restenosis, Sirolimus eluting stent

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.

Interventions

DRUGPioglitazone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026