drugset / Trial / NCT01331967

The Effect of Pioglitazone on Neointima Volume and Characteristics Observed by Optical Coherence Tomography (OCT)

NCT01331967

Phase 4 Completed 94 enrolled Korea University Anam Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2011-02
Primary completion
2013-02
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule 15 mg
Subject Pioglitazone Small molecule 30 mg