The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.

Recurrent stroke and heart attack are major sources of illness and death among the 400,000 Americans who survive a stroke each year. Within 4 years of the initial stroke, 16 percent of patients will have a recurrent stroke and 9 percent will have a heart attack. Prevention of further vascular events, therefore, is critically important to the health of patients with stroke.

The IRIS trial will test a new treatment strategy based on evidence linking insulin resistance to increased risk for stroke and other vascular diseases. Insulin resistance is a condition in which insulin, a normal human hormone, does not work effectively because the body is resistant to its effects. This condition can lead to diabetes and is thought to cause blood vessel disease, including stroke and heart attack, in patients with and without diabetes.

Insulin resistance affects up to 50% of stroke patients and is effectively modified with thiazolidinedione drugs (called "TZDs") used to treat type 2 diabetes. In addition to reducing insulin resistance, these drugs have other favorable effects on blood vessels, reduce blood vessel inflammation, and potentially prevent atherosclerosis. Currently marketed TZDs include rosiglitazone and pioglitazone.

The IRIS is a clinical trial that will enroll 3136 subjects at approximately 100 hospitals in the US and Canada. After an initial screening blood test, each participant will be randomly assigned to take either pioglitazone or placebo tablets. Recruitment will be completed in 3 years, and all participants will be followed for a minimum of 3 years.

Ages Eligible for Study:  45 Years and above,  Genders Eligible for Study:  Both

Criteria

To be eligible you must:

• Be 45 years old or older
• Be non-diabetic
• Have had a recent non-embolic ischemic stroke
• Be insulin resistant as determined by a special fasting blood test