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Comparison Between Pioglitazone and SES With type2 DM

Primary Purpose

Coronary Artery Disease, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
Showa University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Bare metal stent, Major adverse cardiac events, Pioglitazone, Restenosis, Sirolimus eluting stent

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.

    Secondary Outcome Measures

    Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.

    Full Information

    First Posted
    June 4, 2007
    Last Updated
    June 4, 2007
    Sponsor
    Showa University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00482183
    Brief Title
    Comparison Between Pioglitazone and SES With type2 DM
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Showa University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Type 2 Diabetes Mellitus
    Keywords
    Bare metal stent, Major adverse cardiac events, Pioglitazone, Restenosis, Sirolimus eluting stent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pioglitazone
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.
    Time Frame
    6 months after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Youichi Kobayashi, Professor
    Organizational Affiliation
    Showa University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19159848
    Citation
    Nishio K, Shigemitsu M, Kodama Y, Konno N, Katagiri T, Kobayashi Y. Comparison of bare metal stent with pioglitazone versus sirolimus-eluting stent for percutaneous coronary intervention in patients with Type 2 diabetes mellitus. Cardiovasc Revasc Med. 2009 Jan-Mar;10(1):5-11. doi: 10.1016/j.carrev.2008.06.004.
    Results Reference
    derived

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    Comparison Between Pioglitazone and SES With type2 DM

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