This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Insulin Resistance Intervention after Stroke (IRIS) trial will study the effectiveness of a commonly-prescribed medication, pioglitazone, for preventing recurrent stroke and myocardial infarction among non-diabetic patients with a recent ischemic stroke and insulin resistance. Insulin resistance is a common medical condition that may lead to diabetes, stroke and myocardial infarction. By some estimates, insulin resistance affects up to 50 percent of stroke patients. The drug being tested, pioglitazone, reduces insulin resistance and is currently approved for use in diabetes treatment, but it has not been tested for prevention of vascular disease in non-diabetic patients. Over 400,000 Americans survive an ischemic stroke each year. Despite current treatment, within four years of the initial event, 16 percent of stroke patients will have a recurrent stroke and 9 percent will have a myocardial infarction. The IRIS trial includes over 60 research centers in the United States and Canada that will recruit 3,136 participants in the next three years. Eligible participants are men and women age 45 or over without diabetes who have insulin resistance and a recent ischemic stroke. The participants will be randomly assigned to pioglitazone or placebo in addition to their usual therapy. The trial is designed to test the hypothesis that pioglitazone will reduce the risk of recurrent stroke or heart attack by 20 percent during 4 years of therapy.
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