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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,876
a thiazolidinedione drug
an inactive substance
Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction
Time frame: Up to 5 years
Fatal or Non-fatal Stroke Alone
Time frame: 5 years
Acute Coronary Syndrome
Fatal or non-fatal acute myocardial infarction or unstable angina
Time frame: 5 years
Development of Overt Diabetes
Time frame: 5 years
All Cause Mortality
Time frame: 5 years
Decline in Cognitive Status
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.
Time frame: Annual measures from baseline to exit (up to 5 years)
Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure
Time frame: 5 years
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University of Alabama
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Shanti Clinical Trials (NINDS-CRC site)
Colton, California, United States
UCSF-Fresno
Fresno, California, United States
Scripps Clinic
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California-Davis
Sacramento, California, United States
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