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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soon Jun Hong, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01331967
First received: April 5, 2011
Last updated: March 1, 2014
Last verified: March 2014

April 5, 2011
March 1, 2014
February 2011
February 2013   (final data collection date for primary outcome measure)
9 months follow-up neointima volume and neointima characteristics [ Time Frame: 9 months follow-up ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01331967 on ClinicalTrials.gov Archive Site
major adverse cardiovascular events [ Time Frame: 9 months follow-up ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
The Effect of Pioglitazone on Neointima Volume and Characteristics Observed by Optical Coherence Tomography (OCT)
Not Provided

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Diabetic Stable Angina
  • Diabetic Unstable Angina
Drug: Pioglitazone
Pioglitazone 15-30mg, once daily for 9 months
Experimental: Pioglitazone, Placebo
Intervention: Drug: Pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
August 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01331967
PRAISE II
Not Provided
Soon Jun Hong, Korea University Anam Hospital
Korea University Anam Hospital
Not Provided
Not Provided
Korea University Anam Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP