The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers at Eight Months After Zotarolimus-Eluting Stent Implantation in Diabetic Patients
Information source: Korea University Anam Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Coronary Artery Stenosis
Intervention: Pioglitazone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korea University Anam Hospital Official(s) and/or principal investigator(s):
Soon Jun Hong, MD, PhD, Principal Investigator, Affiliation: Korea University Anam Hospital
Sang Yup Lim, MD, PhD, Study Director, Affiliation: Korea University Anam Hospital
Overall contact:
Soon Jun Hong, MD, PhD, Phone: 82-2-920-5445, Email: psyche94@gmail.com
Summary
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.
Clinical Details
Official title: Phase 4 Study of Pioglitazone on Neointima Volume and Inflammatory Markers in Diabetic Patients
Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).
Secondary outcome: Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
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.
1. Primary end point: Comparison of pioglitazone and placebo on 8 months follow-up
neointima volume by intravascular ultrasound (IVUS).
2. Secondary end point: Comparison of pioglitazone and placebo on the changes in the levels
of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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 ≥ 126 mg/dl or PP2 blood glucose ≥ 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
Locations and Contacts
Soon Jun Hong, MD, PhD, Phone: 82-2-920-5445, Email: psyche94@gmail.com
Korea University Anam Hospital, Seoul 136-705, Korea, Republic of; Recruiting
Sang Yup Lim, MD,PhD, Phone: 82-2-920-5625, Email: vnlover@hanmail.net
Additional Information
Starting date: July 2007
Last updated: January 11, 2008
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