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Sponsors and Collaborators: |
Yale University National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00091949 |
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.
Condition | Intervention | Phase |
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Stroke Myocardial Infarction Diabetes |
Drug: pioglitazone Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Insulin Resistance Intervention After Stroke (IRIS) Trial |
Estimated Enrollment: | 3136 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
pioglitazone
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Drug: pioglitazone
a thiazolidinedione drug
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2: Placebo Comparator |
Drug: placebo
an inactive substance
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Recurrent stroke and heart attack are major sources of illness and death among the 400,000 Americans who survive a stroke each year. Within 4 years of the initial 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 drugs (called "TZDs") 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 3136 subjects at approximately 100 hospitals in the US and Canada. After an initial screening blood test, each participant will be randomly assigned to take either pioglitazone or placebo tablets. Recruitment will be completed in 3 years, and all participants will be followed for a minimum of 3 years.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible you must:
Contact: Walter N. Kernan, M.D. | 203-764-7000 |
Principal Investigator: | Walter N. Kernan, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Walter N. Kernan, MD, Principal Investigator ) |
Study ID Numbers: | R01NS044876, CRC |
Study First Received: | September 20, 2004 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00091949 |
Health Authority: | United States: Food and Drug Administration |
stroke heart attack diabetes pioglitazone insulin resistance |
Metabolic Diseases Heart Diseases Pioglitazone Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Diabetes Mellitus 2,4-thiazolidinedione Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Insulin Hyperinsulinism Necrosis Brain Ischemia Brain Infarction Insulin Resistance Metabolic disorder Infarction Glucose Metabolism Disorders Myocardial Infarction |
Hypoglycemic Agents Pathologic Processes Physiological Effects of Drugs |
Nervous System Diseases Cardiovascular Diseases Pharmacologic Actions |