The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers at Eight Months After Zotarolimus-Eluting Stent Implantation in Diabetic Patients

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The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers at Eight Months After Zotarolimus-Eluting Stent Implantation in Diabetic Patients
This study is currently recruiting participants.
Verified by Korea University Anam Hospital, January 2008
Sponsored by: Korea University Anam Hospital

Information provided by: Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00494559

Purpose
People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Several studies have been reported that diabetes increased the risk of cardiovascular mortality in both men and women. With the introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later months have reduced dramatically in several studies. However, even with DESs, diabetic patients showed increased rates of restenosis and late loss index compared with nondiabetic patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era of DESs, no study has demonstrated the clinical and angiographic outcomes in diabetic patients after zotarolimus-eluting stent implantation by using intravascular ultrasound (IVUS).

Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The effect of pioglitazone on neointima volume and inflammatory markers has not been compared in prospective manner after zotarolimus-eluting stent implantation. The purpose of this prospective, randomized, single blinded trial is to compare the effect of pioglitazone on inflammatory markers and neointima volume by using IVUS in diabetic patients.

Condition Intervention Phase
Diabetes Mellitus
Coronary Artery Stenosis
Drug: Pioglitazone
Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Pioglitazone Pioglitazone hydrochloride
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:Phase 4 Study of Pioglitazone on Neointima Volume and Inflammatory Markers in Diabetic Patients

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS). [ Time Frame: 8 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-¦Á, adiponectin). [ Time Frame: 8 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:72
Study Start Date:July 2007
Estimated Primary Completion Date:July 2008 (Final data collection date for primary outcome measure)

Intervention Details:
Drug: Pioglitazone
Actos 15mg once a day before breakfast
Detailed Description:
With the introduction of the DES, the angiographic rates of restenosis have decreased dramatically but less prominently in diabetic patients. Even in the era of DES, diabetes remains a significant predictor of coronary restenosis especially in cases of small baseline and post PCI vessel size, longer stent length, current smokers, and high level of CRP. Restenosis remains a main clinical and angiographic concern after DES implantation especially in diabetic patients. Diabetes has been known as a major risk factor for in-stent restenosis after DES implantation.

Primary end point: Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).
Secondary end point: Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-¦Á, adiponectin).
Eligibility
Ages Eligible for Study:18 Years to 80 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria
Inclusion Criteria:

Age: 18 years and above
Gender eligible for study: both
Diabetic patients either previously diagnosed or newly found diabetes.
Fasting blood glucose ¡Ý 126 mg/dl or PP2 blood glucose ¡Ý 200 mg/dl for newly found diabetes.
Patients with significant de novo coronary artery disease (diameter stenosis > 70%) requiring stent implantation (angina pectoris and/or exercise-induced ischemia).
Patients with informed consent.
Exclusion Criteria:

Acute ST-segment elevation myocardial infarction (MI)
CTO lesions
Left main lesions
Diabetic patients with the use of thiazolidinediones within 3 months
Previous history of PCI or bypass surgery
Patients with any contraindications to the treatment of thiazolidinediones
Pregnant or lactating patients
Chronic alcohol or drug abuse
Hepatic dysfunction
Renal dysfunction
Heart failure (EF < 50%)
Expected life expectancy of < 1 year
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494559

Contacts
Contact: Soon Jun Hong, MD, PhD 82-2-920-5445 psyche94@gmail.com

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Sang Yup Lim, MD,PhD 82-2-920-5625 vnlover@hanmail.net

Sponsors and Collaborators
Korea University Anam Hospital
Investigators
Principal Investigator: Soon Jun Hong, MD, PhD Korea University Anam Hospital
Study Director: Sang Yup Lim, MD, PhD Korea University Anam Hospital
Responsible Party:Korea University Anam Hospital ( Do-Sun Lim )
Study ID Numbers:PRAISE
First Received:June 28, 2007
Last Updated:January 11, 2008
ClinicalTrials.gov Identifier:NCT00494559 [history]
Health Authority:Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
Type 2 Diabetes
Pioglitazone
restenosis

Study placed in the following topic categories:
Metabolic Diseases
Heart Diseases
Pioglitazone
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Constriction, Pathologic
Ischemia
Coronary Stenosis
Coronary Disease
Diabetes Mellitus, Type 2
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Coronary Artery Disease

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions