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Trial NCT00091949

Resource URI: http://static.linkedct.org/resource/trials/NCT00091949
PropertyValue
linkedct:acronym IRIS
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/13832>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/7747>
linkedct:brief_title Insulin Resistance Intervention After Stroke Trial
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linkedct:criteria To be eligible you must: - Be 40 years and older - Be non-diabetic - Have a recent transient ischemic attack or stroke - Be insulin resistant as determined by a special fasting blood test
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 40 Years
linkedct:end_date June 2009
linkedct:enrollment 3136 (xsd:int)
linkedct:firstreceived_date September 20, 2004
linkedct:id NCT00091949
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rdfs:label Trial NCT00091949
linkedct:lastchanged_date June 10, 2009
linkedct:lead_sponsor_agency Yale University
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linkedct:nct_id NCT00091949
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Insulin Resistance Intervention After Stroke (IRIS) Trial
linkedct:org_study_id R01NS044876
linkedct:overall_contact_last_name Walter N. Kernan, M.D.
linkedct:overall_contact_phone 203-764-7000
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linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00091949>
linkedct:phase Phase 3
linkedct:primary_completion_date June 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/41115>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/41362>
linkedct:secondary_id CRC
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/2014>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99701>
linkedct:source Yale University
linkedct:start_date February 2005
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date December 2008