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

• ClinicalTrials.gov Identifier: NCT01331967
• Recruitment Status: Completed
• First Posted: April 8, 2011
• Last Update Posted: March 4, 2014
• Sponsor: Korea University Anam Hospital
• Information provided by (Responsible Party): Soon Jun Hong, Korea University Anam Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Stable Angina; Diabetic Unstable Angina	Drug: Pioglitazone	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: February 2011
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pioglitazone, Placebo	Drug: Pioglitazone; Pioglitazone 15-30mg, once daily for 9 months

Outcome Measures

Primary Outcome Measures :

1. 9 months follow-up neointima volume and neointima characteristics [ Time Frame: 9 months follow-up ]
   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.

Secondary Outcome Measures :

1. major adverse cardiovascular events [ Time Frame: 9 months follow-up ]
   Comparison of pioglitazone and placebo on 9 months follow-up atheroma characteristics. Moreover, major adverse cardiovascular events such as non-fatal MI, death, stroke, and TLR will be compared.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Korea University Anam Hospital

Seoul, Korea, Republic of, 136705

Sponsors and Collaborators

Korea University Anam Hospital

More Information

• Responsible Party: Soon Jun Hong, Associate professor, Korea University Anam Hospital
• ClinicalTrials.gov Identifier: NCT01331967
• Other Study ID Numbers: PRAISE II
• First Posted: April 8, 2011
• Last Update Posted: March 4, 2014
• Last Verified: March 2014

Keywords provided by Soon Jun Hong, Korea University Anam Hospital:

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

Additional relevant MeSH terms:

Angina Pectoris; Angina, Stable; Angina, Unstable; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Pioglitazone; Hypoglycemic Agents; Physiological Effects of Drugs