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Sponsored by: |
Korea University Anam Hospital |
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Information provided by: | Korea University Anam Hospital |
ClinicalTrials.gov Identifier: | NCT00494559 |
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 |
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Diabetes Mellitus Coronary Artery Stenosis |
Drug: Pioglitazone |
Phase IV |
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 |
Estimated Enrollment: | 72 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Soon Jun Hong, MD, PhD | 82-2-920-5445 | psyche94@gmail.com |
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 |
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 |
Study First Received: | June 28, 2007 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00494559 |
Health Authority: | Korea: Food and Drug Administration |
Type 2 Diabetes Pioglitazone restenosis |
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 |
Hypoglycemic Agents Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |