Type 2 diabetic patients treated with oral agents except PPAR gamma agonists and / or patients with insulin resistance measured by IRIS score > 50 with stable coronary artery disease and supposed elective Stent-PCI will be included
Conditions
Interventions
Trade Name: Actos 30mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone HCL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with stable coronary artery disease with planned Stent-PCI and 2. Patients with type II diabetes and / or IRIS score > 50 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: PCI within less than 15 days after acreening visit, use of systemic corticosteroids, Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures, history of esvere multiple allergies, have had more than one unexplained episode of severe hypoglycaemia within 6 months prior to screening visit, progressive fatal disease, pre-treatment with PPar gamma agonists within the 3 months prior to screening, if insulin therapy applicable: initiation of insulin treament within the last 3 months, a history of significant cardiovascular (NYHA stage II-IV), respiratory, gastrointestinal, hepatic (ALAT > 2.5 times normal ref. range), renal (creatinine >1.2 in women and >1.5 mg/dl in men and/or GFR < 45), neurological, psychiatric and or haematological disease as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Pioglitazone in comparison to Placebo on myocardial function and oxidative stress measured by the incidence of Troponin I elevation after elective PTCA;Secondary Objective: To investigate the effect on several other parameters like hs CRP, Nitrotyrosin, asymmetric Dimethylarginin, E-Selectin, Myoglobin, Proinsulin intact, Adiponectin, Visfatin;Primary end point(s): The primary endpoint will be the incidence of cardiac Troponin I elevation (> 1 ULN) at 24 h post PTCA | — |
Countries
Germany
Outcome results
None listed