Comparison Between Pioglitazone and SES With type2 DM

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482183
• Other study ID #: CCT-NAPN-16586
• Secondary ID: CCT-NAPN-16586
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 4, 2007
• Last updated: June 4, 2007
• Start date: July 2003
• Est. completion date: June 2007

Study information

• Verified date: June 2007
• Source: Showa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Pioglitazone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Showa University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.		Within 12minths after the procedure
Secondary	Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.		6 months after procedure