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Comparison Between Pioglitazone and SES With type2 DM

S

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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