Comparison Between Pioglitazone and SES With type2 DM - Full Text View

Sponsor:	Showa University
Information provided by:	Showa University
ClinicalTrials.gov Identifier:	NCT00482183

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Coronary Artery Disease Diabetes

Drug Information available for: Sirolimus Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

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

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	CCT-NAPN-16586, CCT-NAPN-16586
Study First Received:	June 4, 2007
Last Updated:	June 4, 2007
ClinicalTrials.gov Identifier:	NCT00482183 History of Changes
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:

Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Pioglitazone
Myocardial Ischemia
Physiological Effects of Drugs
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010