The Effect of Pioglitazone on Neointima Volume and Characteristics Observed by Optical Coherence Tomography (OCT)
Condition: Diabetic Stable Angina; Diabetic Unstable Angina
MeSH terms: Angina Pectoris; Angina, Stable; Angina, Unstable
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Pioglitazone
Intervention type(s): Drug
Intervention description(s): Pioglitazone 15-30mg, once daily for 9 months
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pioglitazone; optical coherence tomography; microRNA; neointima; major adverse cardiovascular event