The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers
Condition: Diabetes Mellitus; Coronary Artery Stenosis
MeSH terms: Coronary Stenosis; Neointima
Study type: Interventional
Phase: Phase 4

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.
    

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).
    

Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Actos 15mg once a day before breakfast; Placebo drug with the same appearance as actos
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Pioglitazone; restenosis