Coronary Artery Disease Clinical Trial
Official title:
Pilot Trial Studying the Effects of Pioglitazone in Comparison to Placebo on Myocardial Function and Oxidative Stress in Patients With Type II Diabetes and Insulin Resistance Undergoing Elective PTCA. A Randomized Double-blinded Phase II Study.
The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on heart functioning before, during and after stent implantation.
Type 2 diabetes increases the risk of coronary heart disease at least by two to three fold
compared with non-diabetic subjects. Moreover, prospective studies have shown a significant
correlation between several glycemic confounders and morbidity from coronary heart disease
even in patients without diabetes mellitus. In patients with previously diagnosed coronary
heart disease, impaired glucose tolerance was found in 30 to 67 %. The cardiovascular risk
of patients with insulin resistance, with or without glucose intolerance has become more and
more apparent within recent years and quantitative coronary angiographic studies have
revealed a correlation between the severity of coronary heart disease and impaired glucose
tolerance.
A new pharmaceutical class for the intervention of insulin resistance, the peroxisome
proliferator activated receptor (gamma) agonists have been successfully introduced in the
treatment of type 2 diabetes. Beyond their metabolic effects on glucose and lipid
metabolism, peroxisome proliferator activated receptor (gamma) agonists show to exert a
couple of pleiotropic, anti-inflammatory and vasoprotective effects in patients with type 2
diabetes and impaired glucose tolerance.
The incidence and severity of peri-procedural myocardial injury during percutaneous coronary
interventions with stent implantation in diabetic and in non-diabetic patients is an
important prognostic confounder for the patient. Different laboratory biomarkers have been
investigated as diagnostic tools for the estimation of the risk of peri-procedural
myocardial injury. Recent studies have convincingly demonstrated that the risk of subsequent
ischemic heart events is related to the extent of cardiac troponin or CK-MB increase after
coronary intervention, and the prognosis for these individuals is usually worse than that
for patients who do not develop an increase in these biomarkers.
In a recent trial it was shown that pretreatment with atorvastatin could reduce procedural
myocardial injury in elective coronary intervention. The incidence of Troponin I increase
was 48% in the placebo group compared to 20% in the atorvastatin group.
The aim of this study is to investigate the effect of pioglitazone on the incidence of
peri-procedural myocardial injury in patients undergoing percutaneous coronary interventions
with stent implantation. Total participation time is anticipated to be 3 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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