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Clinical Trails at Rush Insulin Resistance Intervention After Stroke Trial (IRIS)
Clinical Trial Protocol ID
07091704

Clinical Trial Investigator Name
Shyam Prabhakaran, MD, MS

Clinical Trial Title

Insulin Resistance Intervention after Stroke Trial (IRIS)



Clinical Trial Protocol Description

The purpose of IRIS is to determine the effectiveness of pioglitazone, compared with placebo, for prevention of recurrent stroke and heart attack among non-diabetic men and women with a recent ischemic stroke or transient ischemic attack (TIA) and insulin resistance.

Approximately 3,136 Subjects (1,568 in each treatment group) at approximately 100 institutions across the United States, Canada and other countries will participate in this study.  At Rush University Medical Center, we expect to recruit approximately 50 patients. The IRIS trial is a randomized, placebo-controlled study.



Clinical Trial Eligibility Criteria

You may be eligible to participate in this study if you:

  • Are 40 years years of age or older at the time of randomization
  • Had an ischemic stroke or TIA no less than 14 days and no more than six months before randomization
  • Have documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity
  • Have both the ability and willingness to provide informed consent

You will be excluded from this study if you:

  • Had a severely disabling stroke as indicated by inability to stand on a scale with assistance and participate in scheduled follow-up activities
  • Have an ischemic stroke or TIA that was related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation
  • Have diabetes mellitus or two fasting plasma blood sugars > 126 mg/dL
  • Have HgbA1c > 7.0%

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.





Contact Name Terry Cole
Contact Phone (312) 563-2208
Contact E-mail rush_stroke@rush.edu
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