Researchers at the School of Medicine and over 60 collaborating research sites received a $33 million grant from the National Institutes of Neurological Disorders and Stroke (NINDS) to conduct a multi-center trial examining a novel approach for treating patients with stroke.
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. The IRIS trial represents a novel approach to stroke prevention, addressing insulin resistance, a common, but often unrecognized risk factor.
Insulin resistance may lead to diabetes, stroke and myocardial infarction. By some estimates, insulin resistance affects up to 50% 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. Stroke is the third leading cause of death in the United States. Despite current treatment, within four years of the initial event, 16% of stroke patients will have a recurrent stroke and 9% will have a myocardial infarction.
"Prevention of further vascular events, therefore, is of major importance," says principal investigator Dr. Walter N. Kernan, associate professor of medicine at the School of Medicine.
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.
"We have designed the trial to test the hypothesis that pioglitazone will reduce the risk of recurrent stroke or heart attack by 20% during four years of therapy," says Kernan.
In addition to Kernan, the Yale investigators include Sandra Alfano (pharmacy), Dr. Lawrence Brass (neurology), Dr. Dawn Bravata (medicine), Dr. Mark Gorman (neurology), Peter Guarino (biostatistics), Dr. Ralph Horwitz (clinical epidemiology, medicine), Dr. Silvio Inzucchi (endocrinology), Peter Peduzzi (biostatistics), Catherine Viscoli (epidemiology) and Dr. Lawrence Young (cardiology). Over 60 collaborating neurologists in the United States and Canada and Barbara Radziszewska of NINDS will also take part in the study.
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