Comparison Between Pioglitazone and SES With type2 DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00482183
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : June 5, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Type 2 Diabetes Mellitus Drug: Pioglitazone Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.
Study Start Date : July 2003
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography. [ Time Frame: Within 12minths after the procedure ]

Secondary Outcome Measures :
  1. Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis. [ Time Frame: 6 months after procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00482183

Sponsors and Collaborators
Showa University
Study Chair: Youichi Kobayashi, Professor Showa University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00482183     History of Changes
Other Study ID Numbers: CCT-NAPN-16586
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: June 5, 2007
Last Verified: June 2007

Keywords provided by Showa University:
Bare metal stent
Major adverse cardiac events
Sirolimus eluting stent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Hypoglycemic Agents