Diabetic Stable Angina Clinical Trial
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 atherosclerotic and inflammatory markers has not been compared in prospective manner after everolimus-eluting stent implantation by OCT. The purpose of this prospective, randomized, open-label trial is to compare the effect of pioglitazone on neointima volume and atherosclerosis progression in type 2 diabetic patients by using OCT. Moreover, changes in neointima characteristics could be analyzed along with the changes in miRNA-21, -126, -143, -145. Major adverse cardiovascular events such as non-fatal MI, death, stroke, and TLR could be compared.
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 DES implantation by using optical coherence tomography
(OCT).
Various microRNAs such as miRNA-21, -126, -143, -145 are involved in the restenosis and
atherosclerosis progression (Figure 1). Changes in these miRNAs from baseline to 9 months
after randomization have never been studied, and the effects of pioglitazone in correlation
with the changes in various miRNAs could be utilized in clinical practices. Comparison of
pioglitazone and placebo on 9 months follow-up neointima volume and neointima
characteristics by optical coherence tomography (OCT) will be conducted.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment