Insulin Resistance Intervention After Stroke Trial
- Conditions
- StrokeMyocardial InfarctionDiabetes
- Interventions
- Drug: placebo
- Registration Number
- NCT00091949
- Lead Sponsor
- Yale University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3876
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo inactive substance Pioglitazone pioglitazone pioglitazone
- Primary Outcome Measures
Name Time Method Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction Up to 5 years
- Secondary Outcome Measures
Name Time Method Fatal or Non-fatal Stroke Alone 5 years Development of Overt Diabetes 5 years All Cause Mortality 5 years Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure 5 years Acute Coronary Syndrome 5 years Fatal or non-fatal acute myocardial infarction or unstable angina
Decline in Cognitive Status Annual measures from baseline to exit (up to 5 years) 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.
Trial Locations
- Locations (180)
Ohio State University
🇺🇸Columbus, Ohio, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Shanti Clinical Trials (NINDS-CRC site)
🇺🇸Colton, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
UCSF-Fresno
🇺🇸Fresno, California, United States
Allegheny Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Albany Medical Center
🇺🇸Albany, New York, United States
SUNY Downstate
🇺🇸Brooklyn, New York, United States
Hattiesburg Clinic (NINDS-CRC site)
🇺🇸Hattiesburg, Mississippi, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
University Duesseldorf/Heinrich-Heine University
🇩🇪Duesseldorf, Germany
Vancouver Island Health Research Centre
🇨🇦Victoria, British Columbia, Canada
CHUM-Centre de recherche, Hôpital Notre-Dame
🇨🇦Montreal, Canada
Ernst-Moritz-Arndt-University Greifswald
🇩🇪Griefswald, Germany
SUNY Buffalo
🇺🇸Buffalo, New York, United States
Burke Medical Research Institute
🇺🇸White Plains, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Intermountain Research Consultants
🇨🇦Thunder Bay, Ontario, Canada
Wolfson Medical Center
🇮🇱Holon, Israel
Alfried Krupp Hospital
🇩🇪Essen, Germany
Freiburg University
🇩🇪Freiburg, Germany
University Hospital Frankfurt
🇩🇪Frankfurt, Germany
Royal Perth
🇦🇺Perth, Western Australia, Australia
Hôpital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
McGill-Montreal General
🇨🇦Montreal, Quebec, Canada
Neurologische Klinik
🇩🇪Bad Neustadt, Germany
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Penn Stat-Hershey Medical Center (NINDS-CRC site)
🇺🇸Hershey, Pennsylvania, United States
Box Hill Hospital (Eastern Health)
🇦🇺Box Hill, Victoria, Australia
McGill-Jewish General
🇨🇦Montreal, Quebec, Canada
Soroka Medical Center
🇮🇱Beer Sheva, Israel
University Heidelberg
🇩🇪Heidelberg, Germany
University Hospital Mainz
🇩🇪Mainz, Germany
University of Ulm
🇩🇪Ulm, Germany
Newcastle upon Tyne
🇬🇧Newcastle upon Tyne, United Kingdom
University of Rome (S. Andrea Hospital)
🇮🇹Roma, Italy
Queen Elizabeth Hospital Gateshead
🇬🇧Gateshead, Tyne And Wear, United Kingdom
Luton and Dubstable Hospital
🇬🇧Luton, United Kingdom
University of Perugia
🇮🇹Perugia, Italy
Sacred Heart Catholic University
🇮🇹Rome, Italy
Monklands Hospital
🇬🇧Airdrie, United Kingdom
Kings College London
🇬🇧London, United Kingdom
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
University of Rome La Sapienza
🇮🇹Rome, Italy
Royal United Hospital
🇬🇧Bath, United Kingdom
Calderdale Royal Hospital
🇬🇧Halifax, United Kingdom
Addenbrookes Foundation NHS Trust (Cambridge)
🇬🇧Cambridge, United Kingdom
Royal Devon and Exeter
🇬🇧Exeter, United Kingdom
Cook County (Stroger) Hospital
🇺🇸Chicago, Illinois, United States
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Rush University
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston University
🇺🇸Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess
🇺🇸Boston, Massachusetts, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, Kent, United Kingdom
National Rehabilitation Hospital
🇺🇸Washington, District of Columbia, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California
🇺🇸San Francisco, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Vanderbilt
🇺🇸Nashville, Tennessee, United States
University of Texas
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Sheba Medical Center
🇮🇱Ramat Gan, Israel
University of Florida
🇺🇸Jacksonville, Florida, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
Billings Clinic
🇺🇸Billings, Montana, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Stobhill Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Wansbeck General Hospital
🇬🇧Ashington, Northumberland, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Southern General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Center for Neurologic Research
🇨🇦Lethbridge, Alberta, Canada
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Saint Georges University of London
🇬🇧London, United Kingdom
North Tyneside General Hospital
🇬🇧Tyne And Wear, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
St. Vincent's Hospital Manhattan
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Cornell University
🇺🇸New York, New York, United States
Southtowns Neurology of WNY (NINDS-CRC site)
🇺🇸West Seneca, New York, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Friedrich Schiller-University Jena
🇩🇪Jena, Germany
B'nai Zion Medical Center
🇮🇱Haifa, Israel
Torbay Hospital (South Devon Healthcare NHS Foundation Trust)
🇬🇧Torquay, United Kingdom
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Robarts Research Institute
🇨🇦London, Ontario, Canada
University Hospital-Dresden
🇩🇪Dresden, Germany
Scripps Clinic
🇺🇸La Jolla, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
MIMA Century Research Associates
🇺🇸Melbourne, Florida, United States
Hartford
🇺🇸Hartford, Connecticut, United States
Pines Neurological Associates (NINDS-CRC site)
🇺🇸Pembroke Pines, Florida, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Ingalls Memorial Hospital (NINDS-CRC site)
🇺🇸Harvey, Illinois, United States
Tri-City Neruology (NINDS-CRC site)
🇺🇸Saint Charles, Illinois, United States
Iowa Health Des Moines Clinical Trials Office
🇺🇸Des Moines, Iowa, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Indiana Medical Research
🇺🇸Elkhart, Indiana, United States
Associates In Neurology (NINDS-CRC site)
🇺🇸Valparaiso, Indiana, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Ruan Neuroscience Center/Mercy Medical Center
🇺🇸Des Moines, Iowa, United States
University of Kentucky Research Foundation
🇺🇸Lexington, Kentucky, United States
Northeast Iowa Medical Education Foundation (NINDS-CRC site)
🇺🇸Waterloo, Iowa, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Penobscot Bay Neurology
🇺🇸Rockport, Maine, United States
Minneapolis Clinic of Neurology
🇺🇸Robbinsdale, Minnesota, United States
St. Luke's Brain and Stroke Institute
🇺🇸Kansas City, Missouri, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Advanced Neurology Specialists
🇺🇸Great Falls, Montana, United States
Kessler Medical Rehab Research Corp
🇺🇸West Orange, New Jersey, United States
Altru Health System
🇺🇸Grand Forks, North Dakota, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Lankenau Institute for Medical Research
🇺🇸Bryn Mawr, Pennsylvania, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Methodist Neurological Institute
🇺🇸Houston, Texas, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Texas, Southwestern
🇺🇸Dallas, Texas, United States
Royal Prince Alfred
🇦🇺Camperstown, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford Park, New South Wales, Australia
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
John Hunter Hospital (University of Newcastle)
🇦🇺New Lambton Heights, New South Wales, Australia
Western Hospital (University of Melbourne)
🇦🇺Footscray, Victoria, Australia
Austin Health (National Stroke Research Institute)
🇦🇺Heidelberg Heights, Victoria, Australia
Ottawa Hospital-General Campus
🇨🇦Ottawa, Ontario, Canada
Klinikum Altenburger Land
🇩🇪Altenburg, Germany
Centre Hospitalier Affilie Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Martin-Luther-Universitaet Halle-Wittenberg
🇩🇪Halle, Germany
University of Erlangen
🇩🇪Erlangen, Germany
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinikum der Universitat Muenchen
🇩🇪Munich, Germany
University Hospital Muenster
🇩🇪Muenster, Germany
Bnai-Zion Medical Center
🇮🇱Haifa, Israel
Rambam Medical Center
🇮🇱Haifa, Israel
Rabin Medical Center-Golda Campus
🇮🇱Petach Tikva, Israel
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
IRCCS FONdazione Istituto Neurologico C. Mondino
🇮🇹Pavia, Italy
University of Laquila
🇮🇹Laquila, Italy
University Vita Salute San Raffaele
🇮🇹Milan, Italy
Genoa University Hospital
🇮🇹Genoa, Italy
Jazzolino Hospital
🇮🇹Vibo Valentia, Italy
Royal Bournemouth
🇬🇧Bournemouth, Dorset, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, Lancashire, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
William Harvey Hospital
🇬🇧Ashford, United Kingdom
Countess of Chester Foundation Trust
🇬🇧Cheshire, United Kingdom
Southend University Hospital
🇬🇧Essex, United Kingdom
Dewsbury District Hospital
🇬🇧Dewsbury, United Kingdom
Devon PCT
🇬🇧Exeter, United Kingdom
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
The Royal Liverpool and Broadgreen University Hospitals
🇬🇧Liverpool, United Kingdom
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of California-Davis
🇺🇸Sacramento, California, United States
Denver Health and Hospital Authority
🇺🇸Denver, Colorado, United States
Floria Neurovascular Institute
🇺🇸Tampa, Florida, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Clinical Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Guilford Neurologic Associates
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States