The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers at Eight Months After Zotarolimus-eluting Stent Implantation in Diabetic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Soon Jun Hong, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT00494559
First received: June 28, 2007
Last updated: March 1, 2014
Last verified: March 2014
  Purpose

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 zotarolimus-eluting stent implantation by using intravascular ultrasound (IVUS).

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 neointima volume and inflammatory markers has not been compared in prospective manner after zotarolimus-eluting stent implantation. The purpose of this prospective, randomized, single blinded trial is to compare the effect of pioglitazone on inflammatory markers and neointima volume by using IVUS in diabetic patients.


Condition Intervention Phase
Diabetes Mellitus
Coronary Artery Stenosis
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Pioglitazone on Neointima Volume and Inflammatory Markers in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS). [ Time Frame: 8 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin). [ Time Frame: 8 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: July 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pioglitazone
    Actos 15mg once a day before breakfast
Detailed Description:

With the introduction of the DES, the angiographic rates of restenosis have decreased dramatically but less prominently in diabetic patients. Even in the era of DES, diabetes remains a significant predictor of coronary restenosis especially in cases of small baseline and post PCI vessel size, longer stent length, current smokers, and high level of CRP. Restenosis remains a main clinical and angiographic concern after DES implantation especially in diabetic patients. Diabetes has been known as a major risk factor for in-stent restenosis after DES implantation.

  1. Primary end point: Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).
  2. Secondary end point: Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 de novo coronary artery disease (diameter stenosis > 70%) requiring stent implantation (angina pectoris and/or exercise-induced ischemia).
  • Patients with informed consent.

Exclusion Criteria:

  • Acute ST-segment elevation myocardial infarction (MI)
  • CTO lesions
  • Left main lesions
  • Diabetic patients with the use of thiazolidinediones within 3 months
  • 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00494559

Locations
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
Principal Investigator: Soon Jun Hong, MD, PhD Korea University Anam Hospital
Study Director: Sang Yup Lim, MD, PhD Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Soon Jun Hong, Associate professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00494559     History of Changes
Other Study ID Numbers: PRAISE
Study First Received: June 28, 2007
Last Updated: March 1, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
Type 2 Diabetes
Pioglitazone
restenosis

Additional relevant MeSH terms:
Coronary Stenosis
Diabetes Mellitus
Cardiovascular Diseases
Coronary Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014