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Comparison Between Pioglitazone and SES With type2 DM

This study has been completed.
Information provided by:
Showa University Identifier:
First received: June 4, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
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 Intervention Phase
Coronary Artery Disease Type 2 Diabetes Mellitus Drug: Pioglitazone Phase 2 Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Showa University:

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

Enrollment: 38
Study Start Date: July 2003
Study Completion Date: June 2007
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.

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.
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Please refer to this study by its identifier: NCT00482183

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00482183     History of Changes
Other Study ID Numbers: CCT-NAPN-16586
Study First Received: June 4, 2007
Last Updated: June 4, 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 processed this record on September 21, 2017