Insulin Resistance Intervention After Stroke Trial (IRIS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Insulin Resistance Intervention After Stroke (IRIS) Trial|
- Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Fatal or Non-fatal Stroke Alone [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Acute Coronary Syndrome [ Time Frame: 5 years ] [ Designated as safety issue: No ]Fatal or non-fatal acute myocardial infarction or unstable angina
- Development of Overt Diabetes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- All Cause Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Decline in Cognitive Status [ Time Frame: Annual measures from baseline to exit (up to 5 years) ] [ Designated as safety issue: No ]Change in modified mental status examination (3MS) score from baseline to exit. Theoretical range of 3MS scores is 0-100. Baseline scores ranged from 22-100.
- Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2005|
|Study Completion Date:||November 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Pioglitazone
a thiazolidinedione drug
Placebo Comparator: Placebo
an inactive substance
Among patients throughout the world who experience a transient ischemic attack (TIA)or ischemic stroke, subsequent stroke and heart attack are major causes of death and disability. Within 4 years of the initial TIA or ischemic 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 (TZD) drugs 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 3936 subjects at approximately 170 hospitals in Australia, Canada, Germany, Israel, Italy, the United Kingdom (UK) and the US. After an initial screening blood test, each participant will be randomly assigned to take either pioglitazone or placebo tablets. Recruitment will be completed during 2005-2012, and all participants will be followed for a minimum of 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091949
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|Principal Investigator:||Walter N. Kernan, M.D.||Yale University|