Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.
Condition: Oxidative Stress; Coronary Artery Disease; Type 2 Diabetes
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on
      heart functioning before, during and after stent implantation.
    

Detailed description: 
      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.
    

Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 30 mg, tablets, orally, once daily for one week; increased to Pioglitazone 45 mg, tablets, orally, once daily for up to two weeks.; Pioglitazone placebo-matching tablets, orally, once daily for up to three weeks.
Other intervention name(s): ACTOS®; AD4833
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: drug effects; Type II Diabetes; Angioplasty, Transluminal, Percutaneous Coronary; Drug Therapy; Heart; physiology; function