The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers

NCT00494559 | Completed Phase 4 DMC

• 1 other identifier: PRAISE
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Coronary Artery Stenosis

Keywords

Type 2 Diabetes; Pioglitazone; restenosis

Outcome Measures

Primary Outcomes (1)

• Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).

  8 month follow-up

Secondary Outcomes (1)

• Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).

  8 months follow-up

Study Arms (2)

Actos

EXPERIMENTAL

Actos group: pioglitazone 15mg or 30mg

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Placebo group: placebo without active medication

Drug: Placebo

Interventions

Pioglitazone DRUG

Actos 15mg once a day before breakfast

Also known as: Actos

Actos

Placebo DRUG

Placebo drug with the same appearance as actos

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 de novo coronary artery disease (diameter stenosis \> 70%) requiring stent implantation (angina pectoris and/or exercise-induced ischemia).
• Patients with informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus; Coronary Stenosis; Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Soon Jun Hong, MD, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Sang Yup Lim, MD, PhD

  Korea University Anam Hospital

  STUDY DIRECTOR

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: June 28, 2007
• First Posted: June 29, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

KR (1)