Diabetes Mellitus Clinical Trial
Official title:
Phase 4 Study of Pioglitazone on Neointima Volume and Inflammatory Markers in Diabetic Patients
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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