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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Anam Hospital
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Age: 18 years and above

• Gender eligible for study: both

• Diabetic patients either previously diagnosed or newly found diabetes.

• Fasting blood glucose ≥ 126 mg/dl or PP2 blood glucose ≥ 200 mg/dl for newly found diabetes.

• Patients with significant coronary artery disease (diameter stenosis > 70%) requiring stent implantation.

• Patients with informed consent.

Exclusion Criteria:

• Diabetic patients with the use of thiazolidinediones

• ACE inhibitor or ARB not allowed during the study period

• Previous history of PCI or bypass surgery

• Patients with any contraindications to the treatment of thiazolidinediones

• Pregnant or lactating patients

• Chronic alcohol or drug abuse

• Hepatic dysfunction

• Renal dysfunction

• Heart failure (EF < 50%)

• Expected life expectancy of < 1 year