PIoglitazone for PrEvention of Restenosis in Diabetic Patients

I5.1 Inclusion criteria

• Patients must be previously diagnosed with type 2 diabetes with documented treatment with insulin, oral hypoglycemics, or diet controlled by medical history. (Undocumented or newly diagnosed diabetics must fulfill the American Diabetes Association Criteria-Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Diabetes Care 2003;26:S5-20)).
• Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;
• Patients with "de novo" coronary lesion (any length) who are eligible for coronary revascularization;
• Target lesion is ≥2.5 mm to ≤3.5mm in diameter (visual estimate);
• Target lesion stenosis is ≥50% (visual estimate);
• Male or Female age >18 years old;
• Patients with one or more lesions to be treated with a sirolimus eluting stent (Cypher, Cordis);
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board.
• At least one lesion must be a complex lesion (see below for details)

5.2 Exclusion criteria

• Patients under age 18 years old;
• Patient has experienced an ST-segment elevation myocardial infarction within the preceding 30 days;
• Active liver disease (ALT>2.5 times upper limit of normal);
• Impaired renal function (creatinine ≥2.5 mg/dL);
• Previous brachytherapy of target vessel;
• Lesion of the Left Main trunk > 50%;
• Target lesion is in a saphenous venous graft or internal mammary graft;
• Target lesion is due to restenosis ;
• Recipient of heart transplant;
• Women who are pregnant or who have the potential to become pregnant during the study;
• Patients with life expectancy of less than one year or factors making clinical follow-up difficult;
• Patients with bleeding diathesis in whom anticoagulant or antiplatelet drug is contraindicated;
• Patient with intolerance/contraindication to Aspirin or Ticlopidine/Clopidogrel or pioglitazone treatment;
• Currently participating in an investigational drug or another device study;
• Patients with leukopenia;
• Patients with neutropenia;
• Documented peptic ulcer or gastric/intestinal bleeding in the last 6 months;
• Patients with thrombocytopenia.