Insulin Resistance Intervention After Stroke Trial (IRIS)

This study is currently recruiting participants.
Verified August 2011 by Yale University
Sponsor:
Collaborators:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00091949
First received: September 20, 2004
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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
Stroke
Myocardial Infarction
Diabetes
Drug: pioglitazone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Insulin Resistance Intervention After Stroke (IRIS) Trial

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Time to occurrence of recurrent fatal or non-fatal stroke, or fatal or non-fatal myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1.time to stroke alone; 2.Diabetes Mellitus; 3.All Cause Mortality; 4.Cognitive Decline (change in score over time for the Modified Mini Mental State Examination) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • stroke, MI, or congestive heart failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3936
Study Start Date: February 2005
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
pioglitazone
Drug: pioglitazone
a thiazolidinedione drug
Placebo Comparator: 2 Drug: placebo
an inactive substance

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 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 3936 subjects at approximately 170 hospitals in Australia, Canada, Germany, Israel, Italy, the 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Ages 40 years or greater at the time of randomization.
  2. Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization
  3. Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity (HOMA).
  4. Both ability and willingness to provide informed consent.
  5. Presence of none of the exclusion criteria.

Exclusion Criteria

Permanent Exclusions

  1. Severely disabling stroke as indicated by an inability to participate in scheduled follow-up activities.
  2. Persons whose ischemic stroke or TIA was related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation.
  3. 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.
  4. HgbA1c > 7.0%.
  5. 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).
  6. History of intolerance to any thiazolidinedione.
  7. Pregnancy or desire to become pregnant.
  8. Oral contraceptive use.
  9. Ongoing use of oral corticosteroids.
  10. History of heart failure
  11. 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.
  12. History of bladder cancer.
  13. 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.

  1. ALT >2.5 times the upper limit of normal.
  2. Hemoglobin <8.5 g/dl.
  3. Moderate or severe pitting edema of the feet or legs (IRIS grade 3 or 4).
  4. Carotid surgery or carotid stenting procedure scheduled (delay randomization until 2 weeks following procedure).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091949

Contacts
Contact: Walter N. Kernan, M.D. 203-764-7000

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Active, not recruiting
Birmingham, Alabama, United States, 35294-0007
University of South Alabama Recruiting
Mobile, Alabama, United States, 36617-2293
Contact: Mel Parnell    251-471-7338    mparnell@usouthal.edu   
Principal Investigator: Richard M. Zweifler, MD         
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721-5023
Contact: Mina Malekniazi    520-626-4150    stroke@neurology.arizona.edu   
Principal Investigator: Bruce M. Coull, MD         
United States, California
Shanti Clinical Trials (NINDS-CRC site) Terminated
Colton, California, United States, 92324
UCSF-Fresno Recruiting
Fresno, California, United States, 93702
Contact: Rebekah Rau    559-459-3845    rrau@fresno.ucsf.edu   
Principal Investigator: Michael Peterson, MD         
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Crystal Sanchez    858-652-5440    sanchez.crystal@scrippshealth.org   
Principal Investigator: Christy Jackson, MD         
University of California Terminated
Los Angeles, California, United States, 90095
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Ana Pardo    323-226-7381    apardo@lacusc.org   
Principal Investigator: Gene Yoi, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Madelleine Garcia    650-725-2326    magarcia@stanford.edu   
Principal Investigator: Maarten Lansberg, MD         
University of California-Davis Recruiting
Sacramento, California, United States, 95817
Contact: Katrina Belova    916-734-6697    katrina.belova@udcmc.ucdavis.edu   
Principal Investigator: Piero Verro, MD         
University of California Recruiting
San Diego, California, United States, 92103-8466
Contact: Nancy Kelly    858-657-7181    nkelly@ucsd.edu   
Principal Investigator: Brett Meyer, MD         
University of California Recruiting
San Francisco, California, United States, 94143-0114
Contact: Terry Yi    415-514-2120    theresa.yi@ucsfmedctr.org   
Principal Investigator: S. Clairborne Johnston, MD         
United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204-4507
Contact: Carol Hennessy    303-436-6363    chenness@dhha.org   
Principal Investigator: Richard L. Hughes, MD         
United States, Connecticut
Hartford Recruiting
Hartford, Connecticut, United States, 06102-5037
Contact: Jennifer Blum    860-545-1977    jjblum@harthosp.org   
Principal Investigator: Isaac E. Silverman, MD         
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Barbara Mendes    203-764-7000    barbara.mendes@yale.edu   
Contact: Kathy Shrauger    203-764-7000    kathy.shrauger@yale.edu   
Principal Investigator: Walter N. Kernan, M.D.         
United States, District of Columbia
National Rehabilitation Hospital Active, not recruiting
Washington, District of Columbia, United States, 20010-2949
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Elizabeth Brooks    352-273-5551    Elizabeth.brooks@neurology.ufl.edu   
Principal Investigator: Michael Waters, MD         
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Contact: Rhonda Calhoun    904-244-9815    rhona.calhoun@jax.ufl.edu   
Principal Investigator: Scott Silliman, MD         
MIMA Century Research Associates Recruiting
Melbourne, Florida, United States, 32901
Contact: Sharon Krubel    321-725-4500 ext 796    sharon.krubel@mima.com   
Principal Investigator: Bhuvanesware Dandapani, MD         
Pines Neurological Associates (NINDS-CRC site) Terminated
Pembroke Pines, Florida, United States, 33026
Floria Neurovascular Institute Recruiting
Tampa, Florida, United States, 33606-3500
Contact: Stephanie Segal    813-250-9101    flneurovascular@gmail.com   
Principal Investigator: Erfan Albakri, MD         
United States, Illinois
Cook County (Stroger) Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Maribeth Ohprecio    312-864-7294    maribeth.ohprecio@hektoen.org   
Principal Investigator: Michael A. Kelly, MD         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Ginny Mezo    312-413-9392    vmezzo@uic.edu   
Principal Investigator: Laura Pedelty, MD         
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Susan Dvojack    312-563-2208    Susan_A_Dvojack@rush.edu   
Principal Investigator: Shyam Prabhakaran, MD         
Ingalls Memorial Hospital (NINDS-CRC site) Recruiting
Harvey, Illinois, United States, 60426
Contact: Deborah Lawrence    798-915-5563    delawren@ingalls.org   
Principal Investigator: Engin Yilmaz, MD         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Linda Chadwick    708-216-6638    lchadwick@lumc.edu   
Principal Investigator: Michael Schneck, MD         
OSF St. Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637-0001
Contact: Judi Beck    309-624-3240    judith.m.beck@osfhealthcare.org   
Principal Investigator: David Wang, DO         
Tri-City Neruology (NINDS-CRC site) Terminated
St. Charles, Illinois, United States, 60175
United States, Indiana
Indiana Medical Research Recruiting
ELkhart, Indiana, United States, 46514
Contact: Shari Hapner    574-296-3903    shapner@elkhartclinic.com   
Principal Investigator: Thomas Vidic, MD         
Associates In Neurology (NINDS-CRC site) Recruiting
Valparaiso, Indiana, United States, 46383
Contact: Carol Parks    219-476-7777 ext 128    cparks@associatesinneurology.com   
Principal Investigator: Richard Strawsburg, MD         
United States, Iowa
Ruan Neuroscience Center/Mercy Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Janelle Gehrke    515-358-0023    jgehrke@mercydesmoines.org   
Principal Investigator: Michael Jacoby, MD         
Iowa Health Des Moines Clinical Trials Office Recruiting
Des Moines, Iowa, United States, 50309
Contact: Janelle Gehrke    515-241-5875    GehrkeJS@ihs.org   
Principal Investigator: Todd Janus, MD         
University of Iowa Recruiting
Iowa City, Iowa, United States, 52246
Contact: Jeri Sieren    319-356-8744    jeri-sieren@uiowa.edu   
Principal Investigator: Enrique Leira, MD         
Northeast Iowa Medical Education Foundation (NINDS-CRC site) Recruiting
Waterloo, Iowa, United States, 50702
Contact: Pamela Trenkamp    319-240-4836    ptrenkam@neimef.org   
Principal Investigator: James Poock, MD         
United States, Kansas
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Donna Collie    316-268-6958    donna_collie@via-christi.org   
Principal Investigator: As'ad Ehtisham, MD         
United States, Kentucky
University of Kentucky Research Foundation Recruiting
Lexington, Kentucky, United States, 40536-0284
Contact: Deborah Taylor    859-257-5560    dtay12@email.uky.edu   
Principal Investigator: Creed Pettigrew, MD         
United States, Louisiana
Steven Zuckerman, MD Withdrawn
Baton Rouge, Louisiana, United States, 70809
Louisiana State University Health Sciences Center Recruiting
Shreveport, Louisiana, United States, 71130-3932
Contact: Erin Eaton    318-813-1452    eeaton@isuhsc.edu   
Principal Investigator: Alireza Minagar, MD         
United States, Maine
Penobscot Bay Neurology Recruiting
Rockport, Maine, United States, 04856
Contact: Jane Sigsbee    207-947-2540    jsigsbee@tidewater.net   
Principal Investigator: Bruce Sigsbee, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287-6953
Contact: Susan Rice    410-614-3460    smrice@jhmi.edu   
Principal Investigator: Robert J. Wityk, MD         
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21209
Contact: Kathy Birnbaum    410-610-5712    kbirnbau@lifebridgehealth.org   
Principal Investigator: Adrian Goldszmidt, MD         
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02118
Contact: Helena Lau    617-414-1171    hlau@bu.edu   
Principal Investigator: Carlos Kase, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114-2695
Contact: Donna Defilippo    617-726-0887    ddefilippo1@partners.org   
Principal Investigator: Karen L. Furie, MD         
Beth Israel Deaconess Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sarah LaRose    617-632-8919    slarose@bidmc.harvard.edu   
Principal Investigator: Sandeep Kumar, MD         
Caritas St. Elizabeth's Medical Center Terminated
Boston, Massachusetts, United States, 02190
United States, Michigan
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
Michigan State University Active, not recruiting
East Lansing, Michigan, United States, 48824
United States, Minnesota
Minneapolis Clinic of Neurology Recruiting
Robbinsdale, Minnesota, United States, 55426
Contact: Amy Tanner    763-520-1542    amytanner@mpls-clinic.com   
Principal Investigator: Irfan Altafullah, MD         
United States, Mississippi
Hattiesburg Clinic (NINDS-CRC site) Terminated
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
St. Luke's Brain and Stroke Institute Terminated
Kansas City, Missouri, United States, 64111
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jill Newgent    314-747-3795    newgentj@neuro.wustl.edu   
Principal Investigator: Abdullah M. Nassief, MD         
St. Louis University Recruiting
St. Louis, Missouri, United States, 63220
Contact: Eve Holzemer    314-977-4971    eve.holzemer@tenehealth.com   
Principal Investigator: Salvatore Cruz-Flores, MD         
St. John's Mercy Medical Center Terminated
St. Louis, Missouri, United States, 63141
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Rbert Verdon    406-255-8476    rverdon@billingsclinic.org   
Principal Investigator: Daniel Rodriguez, MD         
Advanced Neurology Specialists Recruiting
Great Falls, Montana, United States, 59405
Contact: Vicky Jo Reeves    406-761-8673    vreeves@ansresearch.com   
Principal Investigator: Dennis Dietrich, MD         
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68198
Contact: Mary Phillips    402-559-4939    mmphillips@unmc.edu   
Principal Investigator: Pierre Fayad, MD         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Diane Church    603-650-4243    diane.l.church@hitchcock.org   
Principal Investigator: Timothy Lukovits, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08013
Contact: Patricia Niblack    856-968-7269    niblack@cooperhealth.edu   
Principal Investigator: Thomas Mirsen, MD         
Kessler Medical Rehab Research Corp Recruiting
West Orange, New Jersey, United States, 07052
Contact: Siby Varughese    973-243-6984    svarughese@kmrrec.org   
Principal Investigator: Anna Barrett, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: JoAnn Harnar    505-256-5701    jharnar@salud.unm.edu   
Principal Investigator: Glenn D. Graham, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Susan Rauch    518-262-6608    rauchs@mail.amc.edu   
Principal Investigator: Gary Bernardini, MD         
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Mervat Estafanos    201-538-8029    bastamervat@yahoo.com   
Principal Investigator: Miran Salgado, MD         
SUNY Downstate Recruiting
Brooklyn, New York, United States, 11203
Contact: Lorraine Thomas    718-270-1729    lorraine.thomas@downstate.edu   
Principal Investigator: Daniel Rosenbaum, MD         
SUNY Buffalo Recruiting
Buffalo, New York, United States, 14209
Contact: Kathleen Parkes    716-887-5548    kparkes@kaleidahealth.org   
Principal Investigator: Marilou Ching, MD         
Cornell University Active, not recruiting
New York, New York, United States, 10021
St. Vincent's Hospital Manhattan Terminated
New York, New York, United States, 10011
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Justine Zentner    585-275-1204    justine_zentner@urmc.rochester.edu   
Principal Investigator: W. Scott Burgin, MD         
Southtowns Neurology of WNY (NINDS-CRC site) Recruiting
West Seneca, New York, United States, 14224
Contact: Janice Suto    716-712-0890    vascneurology@yahoo.com   
Principal Investigator: Peterkin Lee Kwen, MD         
Burke Medical Research Institute Recruiting
White Plains, New York, United States, 10605
Contact: Rosanne Cirio    914-597-2476    rcirio@burke.org   
Principal Investigator: Pasquale Fonzetti, MD         
United States, North Carolina
Clinical Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Peggy Williams    336-287-5306    pw@triad.rr.com   
Principal Investigator: Andreas Runheim, MD         
Guilford Neurologic Associates Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Pat Henderson    336-273-2511 ext 138    phenderson@guilfordneurologic.com   
Principal Investigator: Pramodkumar Sethi, MD         
United States, North Dakota
Altru Health System Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Renee Hendrickson    701-780-1694    rhendrickson@altru.org   
Principal Investigator: Matthew Roller, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0525
Contact: Jenny Osborne    513-558-4241    jennifer.osborne@uc.edu   
Principal Investigator: Dawn Kleindorfer, MD         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106-4938
Contact: David Korosec    216-844-1800    david.korosec@uhhospitals.org   
Principal Investigator: Sophia Sundararajan, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Donna Prots    216-445-4488    protsd@ccf.org   
Principal Investigator: Irene Katzan, MD         
Metrohealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109-1998
Contact: Dana Cook    216-778-7478    dcook@metrohealth.org   
Principal Investigator: Joseph P. Hanna, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Peggy Notestine    614-293-4975    notestine.11@osu.edu   
Principal Investigator: Andrew Slivka, MD         
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Andrea Korsnack    419-383-3801    akorsnack@meduohio.edu   
Principal Investigator: Gretchen Tietjen, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Corrie Doyle    503-494-8001    doyleco@ohsu.edu   
Principal Investigator: Wayne Clark, MD         
United States, Pennsylvania
Abington Memorial Hospital Terminated
Abington, Pennsylvania, United States, 19001
Lankenau Institute for Medical Research Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Joan Brown    610-649-1175    joanbrown140@aol.com   
Principal Investigator: Gary H. Friday, MD         
Penn Stat-Hershey Medical Center (NINDS-CRC site) Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Kimbra Hitz    717-531-4924    khitz@hmc.psu.edu   
Principal Investigator: Raymond Reichwein, MD         
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Hannah Reimer    215-485-8183    paindromehannah@hotmail.com   
Principal Investigator: Nina Gentile, MD         
Thomas Jefferson University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107-5083
University of Pittsburgh Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213-2582
Allegheny Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Melissa Tan    412-359-3748    mtian@wpahs.org   
Principal Investigator: Ashis Tayal, MD         
United States, Rhode Island
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee Terminated
Memphis, Tennessee, United States, 38163
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37212
Contact: Diane Brown    615-936-0062    diane.brown@vanderbilt.edu   
Principal Investigator: Howard Kirschner, MD         
United States, Texas
University of Texas, Southwestern Recruiting
Dallas, Texas, United States, 75390-8897
Contact: J. Gregory Wright    214-648-0363    james.wright@utsouthwestern.edu   
Principal Investigator: Mark Johnson, MD         
Baylor Research Institute Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Karen Zwerneman    214-820-4795      
Principal Investigator: Lise Labiche, MD         
Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
Contact: Ken Ling, MD    832-576-7998    kenling@gmail.com   
Principal Investigator: James Ling, MD         
University of Texas Terminated
San Antonio, Texas, United States, 78229-3900
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Janet Woodruff    801-581-2631    janet.woodruff@hsc.utah.edu   
Principal Investigator: Elaine Skalabrin, MD         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Sharon Kenney    802-656-9094    sharon.kenney@med.uvm.edu   
Principal Investigator: Mark Gorman, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Colleen Harman, RN    434-924-9664    cph@virginia.edu   
Principal Investigator: Nina Stolenski, MD         
Sentara Medical Group Recruiting
Norfolk, Virginia, United States, 23507
Contact: Janet Rathbun    757-261-4986    jmrccrn@aol.com   
Principal Investigator: Richard Zweifler, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Diane Dowd    608-287-2863    dmd@clinicaltrials.wisc.edu   
Principal Investigator: Justin Sattin, MD         
Marshfield Clinic Terminated
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226-3596
Contact: Erin Brandenburg    414-805-8328    ebrand@mcw.edu   
Principal Investigator: Michel T. Torbey, MD         
Australia, New South Wales
Flinders Medical Centre Recruiting
Bedford Park, New South Wales, Australia, 5042
Contact: Sara Laubscher    61-7-8204-5781    sara.laubscher@health.sa.gov.au   
Principal Investigator: David Schultz, MD         
Royal Prince Alfred Recruiting
Camperstown, New South Wales, Australia, 2050
Contact: Irene Hegarty    61-2-9515-3251    irene.hegarty@sswahs.nsw.gov.au   
Principal Investigator: Craig Anderson, MD         
John Hunter Hospital (University of Newcastle) Recruiting
New Lambton Heights, New South Wales, Australia, 2305
Contact: Michelle Russell    61-2-4921-3481    michelle.russell@hnehealth.nse.gov.au   
Principal Investigator: Mark Parsons, MD         
Australia, Victoria
Box Hill Hospital (Eastern Health) Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Anne Buckland    61-3-9895-0302    anne.buckland@med.monash.edu.au   
Principal Investigator: Christopher Bladin, MD         
Western Hospital (University of Melbourne) Recruiting
Footscray, Victoria, Australia, 3011
Contact: Lyndy-ellen Paxcoe    61-3-8345-6766    lyndyellen@hotmail.com   
Principal Investigator: Tissa Wijeratne, MD         
Austin Health (National Stroke Research Institute) Recruiting
Heidelberg Heights, Victoria, Australia, 3801
Contact: Ros Melling    61-3-9496-2607    rmelling@nsri.org   
Principal Investigator: Helen Dewey, MD         
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Melissa Ugalde    61-3-9342-7743    melissa.ugalde@mh.org.au   
Principal Investigator: Stephen Davis, MD         
Australia, Western Australia
Royal Perth Recruiting
Perth, Western Australia, Australia, 6000
Contact: Anne Claxton    61-8-9224-3461    anne.claxton@health.wa.gov.au   
Principal Investigator: Graeme Hankey, MD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Frederika Herbert    780-407-3383    frederika.herbert@ualberta.ca   
Principal Investigator: Ashfaq Shuaib, MD         
Center for Neurologic Research Recruiting
Lethbridge, Alberta, Canada, T1J0N9
Contact: Carolyn Walker    403-329-4828    c-nr@shaw.ca   
Principal Investigator: Toni Winder, MD         
Canada, British Columbia
Vancouver Island Health Research Centre Recruiting
Victoria, British Columbia, Canada, V8R4R2
Contact: Leslie Atkins    250-370-8111 ext 2840    leslie.atkins@viha.ca   
Principal Investigator: Andrew Penn, MD         
Canada, Ontario
Robarts Research Institute Recruiting
London, Ontario, Canada, N6G2V2
Contact: Margot Giannetti    202-877-1071    margot.giannetti@medstar.net   
Principal Investigator: Richard Chan, MD         
Ottawa Hospital-General Campus Recruiting
Ottawa, Ontario, Canada, k1Y 4E9
Contact: Melodie Mortensen    613-798-5555 ext 16217    mmortensen@ohri.ca   
Principal Investigator: Makul Sharma, MD         
Intermountain Research Consultants Recruiting
Thunder Bay, Ontario, Canada, P7B7C7
Contact: Sandra Stoger    807-684-6044    stogers@tbh.net   
Principal Investigator: Saleem Malik, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Pawel Kostyrko    416-864-5505    kostyrkop@smh.toronto.on.ca   
Principal Investigator: Neville H. Bayer, MD         
Canada, Quebec
Hôpital Charles LeMoyne Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Louise-Marie Beliveau    450-466-5000 ext 2469    louise-marie.beliveau@rrsss16.gouv.qc.ca   
Principal Investigator: Leo Berger, MD         
McGill-Jewish General Recruiting
Montreal, Quebec, Canada, H3T1E2
Contact: Claudia Schanz    514-340-8222 ext 2544    cschanz@neu.jgh.mcgill.ca   
Principal Investigator: Jeffrey Minuk, MD         
McGill-Montreal General Recruiting
Montreal, Quebec, Canada, H3G1A4
Contact: Anne Marie Fontaine    514-934-1934 ext 44303    anne-marie.fontaine@muhc.mcgill.ca   
Principal Investigator: Robert Cote, MD         
Centre Hospitalier Affilie Universitaire de Quebec Recruiting
Quebec City, Quebec, Canada, G1J1Z4
Contact: Sophie Dube    418-649-5892    sophie.dube.cha@ssss.gouvqc.ca   
Principal Investigator: Ariane Mackey, MD         
Canada
CHUM-Centre de recherche, Hôpital Notre-Dame Recruiting
Montreal, Canada, H2L4M1
Contact: Marlene Lapierre    514-890-8000 ext 26242    marlene.lapierre.chum@ssss.gouvqc.ca   
Principal Investigator: Andre Durocher, MD         
Germany
Klinikum Altenburger Land Recruiting
Altenburg, Germany, 04600
Contact: Anett Stoll    49-3447-521364    studienarzt-altenburg@web.de   
Principal Investigator: Jorg Berrouschot, MD         
Neurologische Klinik Recruiting
Bad Neustadt, Germany, 97616
Contact: Hassan Soda    49-9771-9080    h.soda@neurologie-bad-neustadt.de   
Principal Investigator: Bernd Griewing, MD         
University Hospital-Dresden Recruiting
Dresden, Germany, 01307
Contact: Immanuel Dzialowski, MD    49-351-15168    immanuel.dzialowski@uniklinikum-dresden.de   
Principal Investigator: Ulf Becker, MD         
University Duesseldorf/Heinrich-Heine University Recruiting
Duesseldorf, Germany, 40225
Contact: Claudia Koering    49-211-81-19237    claudia.koering@uni-duesseldorf.de   
Principal Investigator: Sebastian Jander         
University of Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Anja Schmidt    49-9131-8534673    anja.schmidt@uk-erlangen.de   
Principal Investigator: Hagen Huttner, MD         
Alfried Krupp Hospital Recruiting
Essen, Germany, 45131
Contact: Birgit Lyss    49-201-434-41418    birgit.lyss@krupp-krankenhaus.de   
Principal Investigator: Peter Berlit, MD         
University Hospital Frankfurt Recruiting
Frankfurt, Germany, 60528
Contact: Isabel Dos Santos    49-69-6301-87745    isabel.dos.santos@uni-frankfurt.de   
Principal Investigator: Tobias Neumann-Haefelin, MD         
Freiburg University Recruiting
Freiburg, Germany, 79106
Contact: Ulrike Bergmann    49-761-270-5193    ulrike.bergmann@uniklinik-freiburg.de   
Principal Investigator: Andreas Hetzel, MD         
Ernst-Moritz-Arndt-University Greifswald Recruiting
Griefswald, Germany, 17475
Contact: Ellen Nieber    49-3834-86-6808    elnieber@uni-greifswald.de   
Principal Investigator: Ulf Schminke, MD         
Martin-Luther-Universitaet Halle-Wittenberg Recruiting
Halle, Germany, 06120
Contact: Dana Richter    49-345-557-7033    dana.richter@medizin.uni-halle.de   
Principal Investigator: Katja Wartenberg, MD         
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Dagmar Otto    49-40-7410-59824    d.ott@uke.de   
Principal Investigator: Michael Rosenkranz, MD         
University Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Perdita Beck    49-6221-56-38121    perdita.beck@med.uni-heidelberg.de   
Principal Investigator: Peter Ringleb, MD         
Friedrich Schiller-University Jena Recruiting
Jena, Germany, 07747
Contact: Claudia Herzau    49-364-19-323405    claudia.herzau@med.uni-jena.de   
Principal Investigator: Otto Witte, MD         
University Hospital Mainz Recruiting
Mainz, Germany, 55131
Contact: Kristine Beutel    49-6131-17-2222    beutel@neurologie.klink.uni-mainz.de   
Principal Investigator: Sven Klimpe, MD         
University Hospital Muenster Recruiting
Muenster, Germany, 48149
Contact: Dorothee Schulte to Buehne    49-251-83-49686    tobuehne@uni-muenster.de   
Principal Investigator: Martin Ritter, MD         
Klinikum der Universitat Muenchen Recruiting
Munich, Germany, 81377
Contact: Angelika Doerr    49-89-7095-3672    angelika.doerr@uni-muenchen.de   
Principal Investigator: Martin Dichgans, MD         
University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Sabine Raubold    49-731-177-5721    sabine.raubold@uni-ulm.de   
Principal Investigator: Roman Huber         
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel, POB151
Contact: Dafna Dalla-Torre    972-54-6368063    dafnad@bgu.ac.il   
Principal Investigator: Itzhak Wirguin, MD         
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Svetlana Mihlina    972-50-206-1771    s_mihlina@rambam.health.gov.il   
Principal Investigator: David Yarnitsky, MD         
B'nai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Ludmila Milman    972-505-773475    Luda.milman@b-zion.org.il   
Principal Investigator: Boaz Weller         
Bnai-Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Ludmila Milman    972-505-773475    luda.milman@b-zion.org.il   
Principal Investigator: Boaz Weller, MD         
Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Mary Israelson    972-3-5010524    maryisraelson@gmail.com   
Principal Investigator: Yair Lampl, MD         
Rabin Medical Center-Golda Campus Recruiting
Petach Tikva, Israel, 49372
Contact: Nahum Roizin    972-3-9372261    nahumr@clalit.org.il   
Principal Investigator: Jonathan Streifler, MD         
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Maya Toashi    972-3-5305744    Maya.toashi@sheba.health.gov.il   
Principal Investigator: David Tanne, MD         
Tel Aviv Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Orit Bar'am    972--3-6973414    oritb@tasmc.health.gov.il   
Principal Investigator: Natan Bornstein, MD         
Italy
Genoa University Hospital Not yet recruiting
Genoa, Italy, 16132
Contact: Carlo Gandolfo, MD    39-010-3537066    gandcaci@unige.it   
Principal Investigator: Carlo Gandolfo, MD         
University of Laquila Recruiting
Laquila, Italy, 67100
Contact: Simona Sacco    39-0862-368533    simona.sacco@yahoo.com   
Principal Investigator: Antonio Carolei, MD         
University Vita Salute San Raffaele Recruiting
Milan, Italy, 20132
Contact: Maria Sessa    39-02-2643-2990    sessa.maria@hsr.it   
Principal Investigator: Giancarlo Comi         
IRCCS FONdazione Istituto Neurologico C. Mondino Recruiting
Pavia, Italy, 27100
Contact: Monica Gattinoni    39-038-2380252    monica.gattinoni@mondino.it   
Principal Investigator: Giuseppe Miciieli, MD         
University of Perugia Recruiting
Perugia, Italy, 06100
Contact: Mauritzio Paciaroni    0755892875    mpaciaroni@hotmail.com   
Principal Investigator: Valeria Caso, MD         
University of Rome (S. Andrea Hospital) Recruiting
Roma, Italy, 00189
Contact: Alessandra Spalloni    39-0633775774    alessandra.spalloni@gmail.com   
Principal Investigator: Maurizia Rasura         
Sacred Heart Catholic University Recruiting
Rome, Italy, 00168
Contact: Vincenzo Di Lazzaro    39-0630-156321    vdilazzaro@rm.unicatt.it   
Principal Investigator: VIncenzo Di Lazzaro, MD         
University of Rome La Sapienza Recruiting
Rome, Italy, 00161
Contact: Maria Teresa Di Mascio    39-0649979595    mariateresa.dimascio@yahoo.it   
Principal Investigator: Danilo Toni, MD         
Jazzolino Hospital Recruiting
Vibo Valentia, Italy, 89900
Contact: Domenico Consoli    096-39-62312    neurologiavv@live.it   
Principal Investigator: Domenico Consoli         
Puerto Rico
University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00936
Contact: Pura Fuste    787-759-0306 ext 228    pfuste@rcm.upr.edu   
Principal Investigator: Fernando Santiago, MD         
United Kingdom
Royal Bournemouth Recruiting
Bournemouth, Dorset, United Kingdom, BH7 7DW
Contact: Anna Orpen    44-1202-704504    anna.orpen@rbch.nhs.uk   
Principal Investigator: Damian Jenkinson, MD         
Queen Elizabeth The Queen Mother Hospital Recruiting
Margate, Kent, United Kingdom, CT9 4AN
Contact: Sally Jones    44-1843-225544 ext 63031    sally.jones@ekht.nhs.uk   
Principal Investigator: George Thomas, MD         
Blackpool Victoria Hospital Recruiting
Blackpool, Lancashire, United Kingdom, FY3 8NR
Contact: Hannah Goddard    44-1253-303729    hannah.goddard@bfwhospitals.nhs.uk   
Principal Investigator: James McIlmoyle, MD         
Wansbeck General Hospital Recruiting
Ashington, Northumberland, United Kingdom, NE63 9JJ
Contact: Catherine Ashbrook-Raby    44-1670-529442    catherine.ashbrook-raby@nhct.nhs.uk   
Principal Investigator: Christopher Price, MD         
Glasgow Royal Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G4 0SF
Contact: Ruth Graham    44-141-232-0970    ruth.graham@ggc.scot.nhs.uk   
Principal Investigator: Peter Langhorne, MD         
Southern General Hospital Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Angela Welch    44-141-201-2836    angelawelch@nhs.net   
Principal Investigator: Keith Muir         
Stobhill Hospital Recruiting
Glasgow, Scotland, United Kingdom, G21 3UT
Contact: Ruth Graham    44-141-201-3012    ruth.graham@ggc.scot.nhs.uk   
Principal Investigator: Christine McAlpine, MD         
Queen Elizabeth Hospital Gateshead Recruiting
Gateshead, Tyne and Wear, United Kingdom, NE9 6SX
Contact: Eleanor Morrell    44-191-445-2843    ellie.morrell@ghnt.nhs.uk   
Principal Investigator: David Barer, MD         
Aberdeen Royal Infirmary Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Contact: Anu Joyson    44-1224-559503    ajoyson@nhs.net   
Principal Investigator: Mary Macleod         
Monklands Hospital Recruiting
Airdrie, United Kingdom, ML6 7UN
Contact: Derek Esson    44-1236-712484    derek.esson@lanarkshire.scot.nhs.uk   
Principal Investigator: J. Mark Barber         
William Harvey Hospital Recruiting
Ashford, United Kingdom, TN24 OLZ
Contact: Linda Cowie    44-1233-616214    linda.cowie@ekht.nhs.uk   
Principal Investigator: David Hargroves, MD         
Royal United Hospital Recruiting
Bath, United Kingdom, BA1 3NG
Contact: Denise Button    44-1225-824120    denise.button@ruh-bath.swest.nhs.uk   
Principal Investigator: Louise Shaw, MB         
Addenbrookes Foundation NHS Trust (Cambridge) Recruiting
Cambridge, United Kingdom, CB2 2QQ
Contact: Julie White    44-1223-256752    juliewhite@addenbrookes.nhs.uk   
Principal Investigator: Eoin O'Brien, MD         
Countess of Chester Foundation Trust Recruiting
Cheshire, United Kingdom, CH2 IUL
Contact: Christine Kelly    44-1244-365894    christine.kelly@coch.nhs.uk   
Principal Investigator: Kausik Chatterjee, MD         
Dewsbury District Hospital Recruiting
Dewsbury, United Kingdom, WF13 4HS
Contact: Ann Needle    44-7966-447-403    ann.needle@nhs.net   
Principal Investigator: Prabal Datta, MD         
Southend University Hospital Recruiting
Essex, United Kingdom, SS0 0RY
Contact: Christopher Khuoge    44-1702-435555 ext 8301    christopher.khuoge@southend.nhs.uk   
Principal Investigator: Paul Guyler, MD         
Devon PCT Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Nicola Wedge    44-1392-406-434    nicola.wedge@rdeft@nhs.uk   
Principal Investigator: William Strain, MD         
Royal Devon and Exeter Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Nicola Wedge    44-1392-406434    nicola.wedge@rdeft.nhs.uk   
Principal Investigator: William Strain, MD         
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
Contact: Caroline Lawlor    44-07890-034950    c.lawlor@nhs.net   
Principal Investigator: Kath Pasco, MD         
Calderdale Royal Hospital Recruiting
Halifax, United Kingdom, HX3 0PW
Contact: Christopher Button    44-1422-224526    christopher.button@cht.nhs.uk   
Principal Investigator: Irfan Shakir, MD         
The Royal Liverpool and Broadgreen University Hospitals Recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Glyn Fletcher    44-151-706-3105    glyn.fletcher@ribuht.nhs.uk   
Principal Investigator: Aravindakshan Manoj, MD         
University Hospital Aintree Recruiting
Liverpool, United Kingdom, L9 7AL
Contact: Helen Martin    44-151-529-3839    helen.martin@aintree.nhs.uk   
Principal Investigator: Ramash Durairaj, MD         
Kings College London Recruiting
London, United Kingdom, SE5 9RS
Contact: Enock Khoromana    44-203-299-7770    enock.khoromana@nhs.net   
Principal Investigator: Lalit Kalra, MD         
Saint Georges University of London Recruiting
London, United Kingdom, SW17 ORE
Contact: Joanna O'Reilly    44-20-8725-3260    joreilly@sgul.ac.uk   
Principal Investigator: Hugh Markus         
Luton and Dubstable Hospital Recruiting
Luton, United Kingdom, LU4 0DZ
Contact: Frances Justin    44-1582-498218    frances.justin@ldh.nhs.uk   
Principal Investigator: Lakshmanan Sekaran, MD         
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Kim Mitchelson    44-1642-854700    kim.mitchelson@nhs.net   
Principal Investigator: David Lance Broughton, MD         
Newcastle upon Tyne Recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Contact: John Davis    44-191-2821688    john.davis@nuth.nhs.uk   
Principal Investigator: Anand Dixit, MD         
Torbay Hospital (South Devon Healthcare NHS Foundation Trust) Recruiting
Torquay, United Kingdom, TQ2 7AA
Contact: Caroline Hilaire    44-1803-656615    caroline.hilaire@nhs.net   
Principal Investigator: Debs Kelly, MD         
North Tyneside General Hospital Recruiting
Tyne and Wear, United Kingdom, NE29 2NH
Contact: Judith Murdy    44-191-2934126    judithmurdy@nhs.net   
Principal Investigator: Helen Rodgers, MD         
Sponsors and Collaborators
Yale University
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Walter N. Kernan, M.D. Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walter N. Kernan, MD, Principal Investigator, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00091949     History of Changes
Other Study ID Numbers: R01NS044876, U01NS044876
Study First Received: September 20, 2004
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
stroke
heart attack
diabetes
pioglitazone
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Infarction
Insulin Resistance
Myocardial Infarction
Stroke
Cerebral Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Hyperinsulinism
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014