Comparison Between Pioglitazone and SES With type2 DM

This study has been completed.
Sponsor:
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
NCT00482183
First received: June 4, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482183

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

No publications provided by Showa University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00482183     History of Changes
Other Study ID Numbers: CCT-NAPN-16586, CCT-NAPN-16586
Study First Received: June 4, 2007
Last Updated: June 4, 2007
Health Authority: Japan: Institutional Review Board

Keywords provided by Showa University:
Bare metal stent
Major adverse cardiac events
Pioglitazone
Restenosis
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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014