Table 1.
Final Inclusion and Exclusion Criteria
| Inclusion Criteria |
|---|
| Ischemic stroke or TIA within 6 months of randomization |
| Insulin resistance as defined by HOMA-IR >3.0 |
| Age ≥ 40 years at randomization 1 |
| Ability and willingness to provide informed consent |
|
Exclusion Criteria
|
| Stroke or TIA related to structural cardiac lesion2 |
| Stroke related to head trauma, proximal arterial dissection or medical procedures3 |
| Diabetes mellitus4 |
| Congestive heart failure (NYHA class 1-4) or history of CHF |
| History of bladder cancer or high risk for bladder cancer5 |
| Active liver disease6 |
| Inability to participate in follow-up activities |
| Irreversible medical conditions with predicted survival <4 years |
| Oral or patch estrogen contraceptive use |
| Ongoing use of oral corticosteroids |
| History of intolerance to a TZD |
| Pregnancy, desire to become pregnant, or currently breastfeeding |
| Current participation in conflicting clinical trial7 |
| ALT>2.5 upper limit of normal |
| Hemoglobin<8.5 gm/dL |
| Moderate to severe pitting edema of feet or legs |
| Carotid surgery or carotid stenting procedure within 14 days of randomization |
Changed from 45 years in October 2007.
Mechanical aortic or mitral valves, left atrial thrombus or ventricular mural thrombus, atrial myxoma or other left-sided cardiac tumors, infective endocarditis, mitral stenosis associated with enlarged left atrium (>5.5 cm), spontaneous echo contrast, or valvular atrial fibrillation.
Stroke within 24 hours of carotid endarterectomy, percutaneous coronary interventional procedure, CABG, intra-aortic balloon pump, valvuloplasty, left-sided electrophysiologic procedures, or cardioversion.
Outpatient use of diabetes medication for diagnosis of diabetes in 90 days preceding screening test or fasting plasma glucose > 125 mg/dL (confirmed on repeat testing) or HgbA1c >=7.0% on screening test.
Current uninvestigated macroscopic hematuria, prior cyclophosphamide exposure, or irradiation to pelvic region.
Known liver disease with cirrhosis, significant cholestasis, portal hypertension, hepatic encephalopathy, hepatic synthetic dysfunction, or expected significant loss of liver function during study. Patients with active hepatitis B were ineligible based on an empiric recommendation from the manufacturer of pioglitazone.
Trial with any of following: Intervention known to affect the incidence of stroke or MI or that is an experimental drug, outcome that includes stroke or MI, exclusion for participation in another trial.