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

NCT01331967 | Completed Phase 4

• 1 other identifier: PRAISE II
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Stable Angina; Diabetic Unstable Angina

Keywords

pioglitazone; optical coherence tomography; microRNA; neointima; major adverse cardiovascular event

Outcome Measures

Primary Outcomes (1)

• 9 months follow-up neointima volume and neointima characteristics

  Comparison of pioglitazone and placebo on 9 months follow-up neointima volume and neointima characteristics by optical coherence tomography (OCT). Moreover, changes in miRNA-21.-126, -143, -145 from baseline to 9 months will be compared.

  9 months follow-up

Secondary Outcomes (1)

• major adverse cardiovascular events

  9 months follow-up

Study Arms (1)

Pioglitazone, Placebo

EXPERIMENTAL

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

Pioglitazone 15-30mg, once daily for 9 months

Pioglitazone, Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoul, 136705, South Korea

Location

MeSH Terms

Conditions

Neointima

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 8, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

KR (1)