Insulin Resistance Intervention After Stroke (IRIS) Trial

Intervention Type: Drug
Study Type: Interventional
Sponsors: National Institute of Neurological Disorders and Stroke (NINDS), Yale University, Takeda Pharmaceuticals North America, Inc.
Participants: 3876
Abstract
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.
* Consult with your doctor before enrolling in clinical trials.
Facilities
Martin-Luther-Universitaet Halle-Wittenberg
Halle, Germany
Countess of Chester Foundation Trust
Cheshire, United Kingdom
St. Luke's Brain and Stroke Institute
Kansas City, United States of America
University Hospital Muenster
Muenster, Germany
Ingalls Memorial Hospital (NINDS-CRC site)
Harvey, United States of America
William Harvey Hospital
Ashford, United Kingdom
Via Christi Regional Medical Center
Wichita, United States of America
Royal Bournemouth
Bournemouth, United Kingdom
Torbay Hospital (South Devon Healthcare NHS Foundation Trust)
Torquay, United Kingdom
University of Toledo
Toledo, United States of America
Indiana Medical Research
Elkhart, United States of America
Center for Neurologic Research
Lethbridge, Canada
University Duesseldorf/Heinrich-Heine University
Duesseldorf, Germany
James Cook University Hospital
Middlesbrough, United Kingdom
Penn Stat-Hershey Medical Center (NINDS-CRC site)
Hershey, United States of America
Southtowns Neurology of WNY (NINDS-CRC site)
West Seneca, United States of America
Alfried Krupp Hospital
Essen, Germany
St. Michael's Hospital
Toronto, Canada
University of California
San Francisco, United States of America
University Heidelberg
Heidelberg, Germany
University of Tennessee
Memphis, United States of America
University of Iowa
Iowa City, United States of America
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
National Rehabilitation Hospital
Washington, United States of America
Cornell University
New York, United States of America
Northeast Iowa Medical Education Foundation (NINDS-CRC site)
Waterloo, United States of America
Sinai Hospital of Baltimore
Baltimore, United States of America
University Hospital Aintree
Liverpool, United Kingdom
Luton and Dubstable Hospital
Luton, United Kingdom
McGill-Montreal General
Montreal, Canada
University of Wisconsin
Madison, United States of America
Sentara Medical Group
Norfolk, United States of America
Royal Surrey County Hospital
Guildford, United Kingdom
University of California-Davis
Sacramento, United States of America
Vancouver Island Health Research Centre
Victoria, Canada
Stanford University
Palo Alto, United States of America
Washington University
Saint Louis, United States of America
Royal Devon and Exeter
Exeter, United Kingdom
Calderdale Royal Hospital
Halifax, United Kingdom
Sacred Heart Catholic University
Rome, Italy
Henry Ford Hospital
Detroit, United States of America
Vanderbilt
Nashville, United States of America
Sheba Medical Center
Ramat Gan, Israel
Oregon Health & Science University
Portland, United States of America
Wansbeck General Hospital
Ashington, United Kingdom
University of New Mexico
Albuquerque, United States of America
Klinikum Altenburger Land
Altenburg, Germany
Boston University
Boston, United States of America
University of Arizona
Tucson, United States of America
Friedrich Schiller-University Jena
Jena, Germany
Associates In Neurology (NINDS-CRC site)
Valparaiso, United States of America
Allegheny Singer Research Institute
Pittsburgh, United States of America
Kings College London
London, United Kingdom
University of Pittsburgh
Pittsburgh, United States of America
Rhode Island Hospital
Providence, United States of America
University Hospital Frankfurt
Frankfurt, Germany
University of Nebraska
Omaha, United States of America
Lankenau Institute for Medical Research
Bryn Mawr, United States of America
Medical College of Wisconsin
Milwaukee, United States of America
University of Rochester
Rochester, United States of America
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Soroka Medical Center
Beer Sheva, Israel
Shanti Clinical Trials (NINDS-CRC site)
Colton, United States of America
University of California
San Diego, United States of America
University of Puerto Rico
San Juan, Puerto Rico
Jazzolino Hospital
Vibo Valentia, Italy
Yale University
New Haven, United States of America
Ohio State University
Columbus, United States of America
University of Erlangen
Erlangen, Germany
Cleveland Clinic Foundation
Cleveland, United States of America
Scripps Clinic
La Jolla, United States of America
Hartford
Hartford, United States of America
University of Alberta
Edmonton, Canada
Dartmouth Hitchcock Medical Center
Lebanon, United States of America
University of Southern California
Los Angeles, United States of America
Wolfson Medical Center
Holon, Israel
Monklands Hospital
Airdrie, United Kingdom
Klinikum der Universitat Muenchen
Munich, Germany
Queen Elizabeth Hospital Gateshead
Gateshead, United Kingdom
Stobhill Hospital
Glasgow, United Kingdom
Austin Health (National Stroke Research Institute)
Heidelberg Heights, Australia
Neurologische Klinik
Bad Neustadt, Germany
Newcastle upon Tyne
Newcastle Upon Tyne, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
University of Rome La Sapienza
Rome, Italy
SUNY Downstate
Brooklyn, United States of America
University Hospital-Dresden
Dresden, Germany
University of Kentucky Research Foundation
Lexington, United States of America
Ernst-Moritz-Arndt-University Greifswald
Griefswald, Germany
Devon PCT
Exeter, United Kingdom
University of Vermont
Burlington, United States of America
St. Vincent's Hospital Manhattan
New York, United States of America
Billings Clinic
Billings, United States of America
Denver Health and Hospital Authority
Denver, United States of America
University of South Alabama
Mobile, United States of America
Ottawa Hospital-General Campus
Ottawa, Canada
Johns Hopkins
Baltimore, United States of America
SUNY Buffalo
Buffalo, United States of America
Rambam Medical Center
Haifa, Israel
Thomas Jefferson University
Philadelphia, United States of America
Hattiesburg Clinic (NINDS-CRC site)
Hattiesburg, United States of America
University Hospital Mainz
Mainz, Germany
University of Ulm
Ulm, Germany
Rabin Medical Center-Golda Campus
Petach Tikva, Israel
Iowa Health Des Moines Clinical Trials Office
Des Moines, United States of America
UCSF-Fresno
Fresno, United States of America
Cook County (Stroger) Hospital
Chicago, United States of America
Royal Prince Alfred
Camperstown, Australia
University of Texas
San Antonio, United States of America
Southend University Hospital
Essex, United Kingdom
Saint Georges University of London
London, United Kingdom
University of Alabama
Birmingham, United States of America
Robarts Research Institute
London, Canada
North Tyneside General Hospital
Tyne And Wear, United Kingdom
Michigan State University
East Lansing, United States of America
University of Cincinnati
Cincinnati, United States of America
Albany Medical Center
Albany, United States of America
Glasgow Royal Infirmary
Glasgow, United Kingdom
Addenbrookes Foundation NHS Trust (Cambridge)
Cambridge, United Kingdom
Temple University
Philadelphia, United States of America
St. John's Mercy Medical Center
Saint Louis, United States of America
Freiburg University
Freiburg, Germany
Kessler Medical Rehab Research Corp
West Orange, United States of America
University of Laquila
Laquila, Italy
Case Western Reserve University
Cleveland, United States of America
Royal Perth
Perth, Australia
Massachusetts General Hospital
Boston, United States of America
Hôpital Charles LeMoyne
Greenfield Park, Canada
University of Rome (S. Andrea Hospital)
Roma, Italy
Tel Aviv Medical Center
Tel Aviv, Israel
Marshfield Clinic
Marshfield, United States of America
Intermountain Research Consultants
Thunder Bay, Canada
Pines Neurological Associates (NINDS-CRC site)
Pembroke Pines, United States of America
Guilford Neurologic Associates
Winston-salem, United States of America
Advanced Neurology Specialists
Great Falls, United States of America
Caritas St. Elizabeth's Medical Center
Boston, United States of America
Metrohealth Medical Center
Cleveland, United States of America
MIMA Century Research Associates
Melbourne, United States of America
Altru Health System
Grand Forks, United States of America
University of Florida
Gainesville, United States of America
Baylor Research Institute
Dallas, United States of America
B'nai Zion Medical Center
Haifa, Israel
John Hunter Hospital (University of Newcastle)
New Lambton Heights, Australia
Box Hill Hospital (Eastern Health)
Box Hill, Australia
University of Texas, Southwestern
Dallas, United States of America
Floria Neurovascular Institute
Tampa, United States of America
Louisiana State University Health Sciences Center
Shreveport, United States of America
New York Methodist Hospital
Brooklyn, United States of America
Loyola University Medical Center
Maywood, United States of America
Queen Elizabeth The Queen Mother Hospital
Margate, United Kingdom
Western Hospital (University of Melbourne)
Footscray, Australia
University Vita Salute San Raffaele
Milan, Italy
University of California
Los Angeles, United States of America
Methodist Neurological Institute
Houston, United States of America
Centre Hospitalier Affilie Universitaire de Quebec
Quebec City, Canada
St. Louis University
Saint Louis, United States of America
Abington Memorial Hospital
Abington, United States of America
McGill-Jewish General
Montreal, Canada
Dewsbury District Hospital
Dewsbury, United Kingdom
Southern General Hospital
Glasgow, United Kingdom
Flinders Medical Centre
Bedford Park, Australia
Penobscot Bay Neurology
Rockport, United States of America
Minneapolis Clinic of Neurology
Robbinsdale, United States of America
Royal United Hospital
Bath, United Kingdom
Rush University
Chicago, United States of America
University of Florida
Jacksonville, United States of America
Burke Medical Research Institute
White Plains, United States of America
Royal Melbourne Hospital
Parkville, Australia
University of Perugia
Perugia, Italy
OSF St. Francis Medical Center
Peoria, United States of America
Cooper University Hospital
Camden, United States of America
Tri-City Neruology (NINDS-CRC site)
Saint Charles, United States of America
Beth Israel Deaconess
Boston, United States of America
University of Virginia
Charlottesville, United States of America
CHUM-Centre de recherche, Hôpital Notre-Dame
Montreal, Canada
Genoa University Hospital
Genoa, Italy
University of Illinois
Chicago, United States of America
IRCCS FONdazione Istituto Neurologico C. Mondino
Pavia, Italy
Bnai-Zion Medical Center
Haifa, Israel
University of Utah
Salt Lake City, United States of America
Clinical Research of Winston-Salem
Winston-salem, United States of America
Ruan Neuroscience Center/Mercy Medical Center
Des Moines, United States of America
The Royal Liverpool and Broadgreen University Hospitals
Liverpool, United Kingdom
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Eligibilities
Sex: All
Minimum Age: 40
Healthy Volunteers: No
Inclusion Criteria
- Ages 40 years or greater at the time of randomization.
- Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization
- Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity (HOMA).
- Both ability and willingness to provide informed consent.
- Presence of none of the exclusion criteria.
Exclusion Criteria
Permanent Exclusions
- Severely disabling stroke as indicated by an inability to participate in scheduled follow-up activities.
- Persons whose ischemic stroke or TIA was related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation.
- Diabetes mellitus as defined by recent use of medication for diabetes as an out-patient (*see note below) or two fasting plasma blood sugars > 126 mg/dL.
- HgbA1c > 7.0%.
- Irreversible medical conditions likely to affect short-term survival or ability to participate in the study protocol. These include:
- Cancer or other chronic disease with poor prognosis (predicted survival of less than four years).
- Severe neurologic or psychiatric disease that would complicate the evaluation of study outcomes (e.g., dementia or schizophrenia).
- History of intolerance to any thiazolidinedione.
- Pregnancy or desire to become pregnant.
- Oral contraceptive use.
- Ongoing use of oral corticosteroids.
- History of heart failure
- Active liver disease as defined by known liver disease accompanied by cirrhosis, significant cholestasis, portal hypertension, hepatic encephalopathy, hepatic synthetic dysfunction, or expected significant loss of liver function over the course of the study.
- History of bladder cancer.
- Current participation in a conflicting clinical trial. A conflicting clinical trial is defined as a trial with any of following:
- Intervention that is known to affect the incidence of stroke or myocardial infarction.
- Intervention that is an experimental drug.
- Outcome that includes stroke or myocardial infarction.
- Exclusion for participation in another trial.
Temporary Exclusions Persons with temporary exclusions may be enrolled as soon as the exclusion has resolved.
- Alanine aminotransferase (ALT) >2.5 times the upper limit of normal.
- Hemoglobin <8.5 g/dl.
- Moderate or severe pitting edema of the feet or legs (IRIS grade 3 or 4).
- Carotid surgery or carotid stenting procedure scheduled (delay randomization until 2 weeks following procedure).
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Relevant Conditions

Apoplexy, Heart Attack, Stroke

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