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Comparison Between Pioglitazone and SES With type2 DM

NCT ID: NCT00482183

Last Updated: 2007-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pioglitazone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa University

OTHER

Sponsor Role lead

Principal Investigators

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Youichi Kobayashi, Professor

Role: STUDY_CHAIR

Showa University

References

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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.

Reference Type DERIVED
PMID: 19159848 (View on PubMed)

Other Identifiers

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CCT-NAPN-16586

Identifier Type: -

Identifier Source: secondary_id

CCT-NAPN-16586

Identifier Type: -

Identifier Source: org_study_id