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AzTrials

StrokePhase 3IRISNCT00091949

Insulin Resistance Intervention After Stroke Trial

A Phase 3 study testing pioglitazone in people with Stroke and Myocardial Infarction, run by Yale University at 183 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Stroke, Myocardial Infarction, Diabetes
What is being tested?
pioglitazone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,876 participants
Where
183 sitesin 8 countries
Study dates
Feb 2005to Nov 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 24Show fewer
  • 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.
  • 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).

Trial locations and contacts

183 sites in 8 countries.

183 sites in 8 countries

United States99 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico

    Albuquerque, New Mexico, 87108

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21209

  • Johns Hopkins

    Baltimore, Maryland, 21287-6953

  • Billings Clinic

    Billings, Montana, 59101

  • University of Alabama

    Birmingham, Alabama, 35294-0007

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2695

  • Boston University

    Boston, Massachusetts, 02118

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02190

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215

  • SUNY Downstate

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Lankenau Institute for Medical Research

    Bryn Mawr, Pennsylvania, 19010

  • SUNY Buffalo

    Buffalo, New York, 14209

  • University of Vermont

    Burlington, Vermont, 05405

  • Cooper University Hospital

    Camden, New Jersey, 08013

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Cook County (Stroger) Hospital

    Chicago, Illinois, 60612

  • Rush University

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0525

  • Case Western Reserve University

    Cleveland, Ohio, 44106-4938

  • Metrohealth Medical Center

    Cleveland, Ohio, 44109-1998

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Shanti Clinical Trials (NINDS-CRC site)

    Colton, California, 92324

  • Ohio State University

    Columbus, Ohio, 43210

  • Baylor Research Institute

    Dallas, Texas, 75246

  • University of Texas, Southwestern

    Dallas, Texas, 75390-8897

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204-4507

  • Iowa Health Des Moines Clinical Trials Office

    Des Moines, Iowa, 50309

  • Ruan Neuroscience Center/Mercy Medical Center

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Michigan State University

    East Lansing, Michigan, 48824

  • Indiana Medical Research

    Elkhart, Indiana, 46514

  • UCSF-Fresno

    Fresno, California, 93702

  • University of Florida

    Gainesville, Florida, 32610

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • Advanced Neurology Specialists

    Great Falls, Montana, 59405

  • Hartford

    Hartford, Connecticut, 06102-5037

  • Ingalls Memorial Hospital (NINDS-CRC site)

    Harvey, Illinois, 60426

  • Hattiesburg Clinic (NINDS-CRC site)

    Hattiesburg, Mississippi, 39401

  • Penn Stat-Hershey Medical Center (NINDS-CRC site)

    Hershey, Pennsylvania, 17033

  • Methodist Neurological Institute

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52246

  • University of Florida

    Jacksonville, Florida, 32209

  • St. Luke's Brain and Stroke Institute

    Kansas City, Missouri, 64111

  • Scripps Clinic

    La Jolla, California, 92037

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Research Foundation

    Lexington, Kentucky, 40536-0284

  • University of Southern California

    Los Angeles, California, 90033

  • University of California

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • MIMA Century Research Associates

    Melbourne, Florida, 32901

  • University of Tennessee

    Memphis, Tennessee, 38163

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-3596

  • University of South Alabama

    Mobile, Alabama, 36617-2293

  • Vanderbilt

    Nashville, Tennessee, 37212

  • Yale University

    New Haven, Connecticut, 06519

  • St. Vincent's Hospital Manhattan

    New York, New York, 10011

  • Cornell University

    New York, New York, 10021

  • Sentara Medical Group

    Norfolk, Virginia, 23507

  • University of Nebraska

    Omaha, Nebraska, 68198

  • Stanford University

    Palo Alto, California, 94304

  • Pines Neurological Associates (NINDS-CRC site)

    Pembroke Pines, Florida, 33026

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637-0001

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107-5083

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213-2582

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • Rhode Island Hospital

    Providence, Rhode Island, 02905

  • Minneapolis Clinic of Neurology

    Robbinsdale, Minnesota, 55426

  • University of Rochester

    Rochester, New York, 14642

  • Penobscot Bay Neurology

    Rockport, Maine, 04856

  • University of California-Davis

    Sacramento, California, 95817

  • Tri-City Neruology (NINDS-CRC site)

    Saint Charles, Illinois, 60175

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of Texas

    San Antonio, Texas, 78229-3900

  • University of California

    San Diego, California, 92103-8466

  • University of California

    San Francisco, California, 94143-0114

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana, 71130-3932

  • Washington University

    St Louis, Missouri, 63110

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • St. Louis University

    St Louis, Missouri, 63220

  • Floria Neurovascular Institute

    Tampa, Florida, 33606-3500

  • University of Toledo

    Toledo, Ohio, 43614

  • University of Arizona

    Tucson, Arizona, 85721-5023

  • Associates In Neurology (NINDS-CRC site)

    Valparaiso, Indiana, 46383

  • National Rehabilitation Hospital

    Washington D.C., District of Columbia, 20010-2949

  • Northeast Iowa Medical Education Foundation (NINDS-CRC site)

    Waterloo, Iowa, 50702

  • Kessler Medical Rehab Research Corp

    West Orange, New Jersey, 07052

  • Southtowns Neurology of WNY (NINDS-CRC site)

    West Seneca, New York, 14224

  • Burke Medical Research Institute

    White Plains, New York, 10605

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Clinical Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Guilford Neurologic Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

United Kingdom29 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Monklands Hospital

    Airdrie, ML6 7UN

  • William Harvey Hospital

    Ashford, TN24 OLZ

  • Wansbeck General Hospital

    Ashington, Northumberland, NE63 9JJ

  • Royal United Hospital

    Bath, BA1 3NG

  • Blackpool Victoria Hospital

    Blackpool, Lancashire, FY3 8NR

  • Royal Bournemouth

    Bournemouth, Dorset, BH7 7DW

  • Addenbrookes Foundation NHS Trust (Cambridge)

    Cambridge, CB2 2QQ

  • Countess of Chester Foundation Trust

    Cheshire, CH2 IUL

  • Dewsbury District Hospital

    Dewsbury, WF13 4HS

  • Southend University Hospital

    Essex, SS0 0RY

  • Devon PCT

    Exeter, EX2 5DW

  • Royal Devon and Exeter

    Exeter, EX2 5DW

  • Queen Elizabeth Hospital Gateshead

    Gateshead, Tyne and Wear, NE9 6SX

  • Stobhill Hospital

    Glasgow, Scotland, G21 3UT

  • Glasgow Royal Infirmary

    Glasgow, Scotland, G4 0SF

  • Southern General Hospital

    Glasgow, Scotland, G51 4TF

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Calderdale Royal Hospital

    Halifax, HX3 0PW

  • The Royal Liverpool and Broadgreen University Hospitals

    Liverpool, L7 8XP

  • University Hospital Aintree

    Liverpool, L9 7AL

  • Kings College London

    London, SE5 9RS

  • Saint Georges University of London

    London, SW17 ORE

  • Luton and Dubstable Hospital

    Luton, LU4 0DZ

  • Queen Elizabeth The Queen Mother Hospital

    Margate, Kent, CT9 4AN

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Newcastle upon Tyne

    Newcastle upon Tyne, NE1 4LP

  • Torbay Hospital (South Devon Healthcare NHS Foundation Trust)

    Torquay, TQ2 7AA

  • North Tyneside General Hospital

    Tyne and Wear, NE29 2NH

Other trials in United Kingdom

Germany17 sites

  • Klinikum Altenburger Land

    Altenburg, 04600

  • Neurologische Klinik

    Bad Neustadt an der Saale, 97616

  • University Hospital-Dresden

    Dresden, 01307

  • University Duesseldorf/Heinrich-Heine University

    Düsseldorf, 40225

  • University of Erlangen

    Erlangen, 91054

  • Alfried Krupp Hospital

    Essen, 45131

  • University Hospital Frankfurt

    Frankfurt, 60528

  • Freiburg University

    Freiburg im Breisgau, 79106

  • Ernst-Moritz-Arndt-University Greifswald

    Greifswald, 17475

  • Martin-Luther-Universitaet Halle-Wittenberg

    Halle, 06120

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

  • University Heidelberg

    Heidelberg, 69120

  • Friedrich Schiller-University Jena

    Jena, 07747

  • University Hospital Mainz

    Mainz, 55131

  • Klinikum der Universitat Muenchen

    Munich, 81377

  • University Hospital Muenster

    Münster, 48149

  • University of Ulm

    Ulm, 89081

Other trials in Germany

Canada12 sites

  • University of Alberta

    Edmonton, Alberta, T6G2B7

  • Hôpital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Center for Neurologic Research

    Lethbridge, Alberta, T1J0N9

  • Robarts Research Institute

    London, Ontario, N6G2V2

  • McGill-Montreal General

    Montreal, Quebec, H3G1A4

  • McGill-Jewish General

    Montreal, Quebec, H3T1E2

  • CHUM-Centre de recherche, Hôpital Notre-Dame

    Montreal, H2L4M1

  • Ottawa Hospital-General Campus

    Ottawa, Ontario, k1Y 4E9

  • Centre Hospitalier Affilie Universitaire de Quebec

    Québec, Quebec, G1J1Z4

  • Intermountain Research Consultants

    Thunder Bay, Ontario, P7B7C7

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

  • Vancouver Island Health Research Centre

    Victoria, British Columbia, V8R4R2

Other trials in Canada

Italy9 sites

  • Genoa University Hospital

    Genoa, 16132

  • University of Laquila

    Laquila, 67100

  • University Vita Salute San Raffaele

    Milan, 20132

  • IRCCS FONdazione Istituto Neurologico C. Mondino

    Pavia, 27100

  • University of Perugia

    Perugia, 06100

  • University of Rome (S. Andrea Hospital)

    Roma, 00189

  • University of Rome La Sapienza

    Rome, 00161

  • Sacred Heart Catholic University

    Rome, 00168

  • Jazzolino Hospital

    Vibo Valentia, 89900

Other trials in Italy

Australia8 sites

  • Flinders Medical Centre

    Bedford Park, New South Wales, 5042

  • Box Hill Hospital (Eastern Health)

    Box Hill, Victoria, 3128

  • Royal Prince Alfred

    Camperstown, New South Wales, 2050

  • Western Hospital (University of Melbourne)

    Footscray, Victoria, 3011

  • Austin Health (National Stroke Research Institute)

    Heidelberg Heights, Victoria, 3801

  • John Hunter Hospital (University of Newcastle)

    New Lambton Heights, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth

    Perth, Western Australia, 6000

Other trials in Australia

Israel8 sites

  • Soroka Medical Center

    Beersheba, POB151

  • B'nai Zion Medical Center

    Haifa, 31048

  • Bnai-Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Wolfson Medical Center

    Holon, 58100

  • Rabin Medical Center-Golda Campus

    Petah Tikva, 49372

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Medical Center

    Tel Aviv, 64239

Other trials in Israel

Puerto Rico1 site

  • University of Puerto Rico

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: Insulin Resistance Intervention After Stroke (IRIS) Trial

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.

Read the 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.

Being tested
pioglitazone, placebo
Keywords
stroke, heart attack, diabetes, pioglitazone, insulin resistance
Medical subject headings
Stroke, Myocardial Infarction, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pioglitazoneDrug

    a thiazolidinedione drug

  • placeboDrug

    an inactive substance

Study groups in NCT00091949
Study groupRoleWhat they receive
PioglitazoneActive comparatorpioglitazone
Receives: Drug: pioglitazone
PlaceboPlacebo comparatorinactive substance
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction

    Measured: Up to 5 years

Secondary outcomes (6)

  1. Fatal or Non-fatal Stroke Alone

    Measured: 5 years

  2. Acute Coronary Syndrome

    Fatal or non-fatal acute myocardial infarction or unstable angina

    Measured: 5 years

  3. Development of Overt Diabetes

    Measured: 5 years

  4. All Cause Mortality

    Measured: 5 years

  5. Decline in Cognitive Status

    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.

    Measured: Annual measures from baseline to exit (up to 5 years)

  6. Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2004 (estimated)
  2. Study startFeb 2005
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
3,876 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091949
Sponsor's protocol ID
0201013034
Other IDs
5U01NS044876-10
Acronym
IRIS
Status last verified
Sep 2016
First submitted
20 Sep 2004
Last updated
27 Apr 2020
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Viscoli CM, Brass LM, Carolei A, Conwit R, Ford GA, Furie KL, Gorman M, Guarino PD, Inzucchi SE, Lovejoy AM, Parsons MW, Peduzzi PN, Ringleb PA, Schwartz GG, Spence JD, Tanne D, Young LH, Kernan WN; IRIS Trial investigators. Pioglitazone for secondary prevention after ischemic stroke and transient ischemic attack: rationale and design of the Insulin Resistance Intervention after Stroke Trial. Am Heart J. 2014 Dec;168(6):823-9.e6. doi: 10.1016/j.ahj.2014.07.016. Epub 2014 Jul 28.

    PubMed 25458644

  • Kernan WN, Viscoli CM, Demarco D, Mendes B, Shrauger K, Schindler JL, McVeety JC, Sicklick A, Moalli D, Greco P, Bravata DM, Eisen S, Resor L, Sena K, Story D, Brass LM, Furie KL, Gutmann L, Hinnau E, Gorman M, Lovejoy AM, Inzucchi SE, Young LH, Horwitz RI; IRIS Trial Investigators. Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs). Neurology. 2009 Apr 14;72(15):1345-51. doi: 10.1212/WNL.0b013e3181a0fda3.

    PubMed 19365056

  • Kernan W, Viscoli C, Brass L, Amatangelo M, Birch A, Clark W, Conwit R, Furie K, Gorman M, Pesapane B, Kleindorfer D, Lovejoy A, Osborne J, Silliman S, Zweifler R, Horwitz R. Boosting enrolment in clinical trials: validation of a regional network model. Clin Trials. 2011 Oct;8(5):645-53. doi: 10.1177/1740774511414925. Epub 2011 Aug 8.

    PubMed 21824978

  • Ridha M, Zhang C, McCullough S, Viscoli CM, Sharma R, Kamel H, Merkler AE. Silent Myocardial Infarction and Risk of Stroke Recurrence: A Post Hoc Analysis of the IRIS Trial. J Am Heart Assoc. 2025 Feb 18;14(4):e037663. doi: 10.1161/JAHA.124.037663. Epub 2025 Feb 8.

    PubMed 39921499

  • Spence JD, Viscoli CM, Inzucchi SE, Dearborn-Tomazos J, Ford GA, Gorman M, Furie KL, Lovejoy AM, Young LH, Kernan WN; IRIS Investigators. Pioglitazone Therapy in Patients With Stroke and Prediabetes: A Post Hoc Analysis of the IRIS Randomized Clinical Trial. JAMA Neurol. 2019 May 1;76(5):526-535. doi: 10.1001/jamaneurol.2019.0079.

    PubMed 30734043

  • Young LH, Viscoli CM, Schwartz GG, Inzucchi SE, Curtis JP, Gorman MJ, Furie KL, Conwit R, Spatz ES, Lovejoy A, Abbott JD, Jacoby DL, Kolansky DM, Ling FS, Pfau SE, Kernan WN; IRIS Investigators. Heart Failure After Ischemic Stroke or Transient Ischemic Attack in Insulin-Resistant Patients Without Diabetes Mellitus Treated With Pioglitazone. Circulation. 2018 Sep 18;138(12):1210-1220. doi: 10.1161/CIRCULATIONAHA.118.034763.

    PubMed 29934374

  • Yaghi S, Furie KL, Viscoli CM, Kamel H, Gorman M, Dearborn J, Young LH, Inzucchi SE, Lovejoy AM, Kasner SE, Conwit R, Kernan WN; IRIS Trial Investigators. Pioglitazone Prevents Stroke in Patients With a Recent Transient Ischemic Attack or Ischemic Stroke: A Planned Secondary Analysis of the IRIS Trial (Insulin Resistance Intervention After Stroke). Circulation. 2018 Jan 30;137(5):455-463. doi: 10.1161/CIRCULATIONAHA.117.030458. Epub 2017 Oct 30.

    PubMed 29084736

  • Kernan WN, Viscoli CM, Dearborn JL, Kent DM, Conwit R, Fayad P, Furie KL, Gorman M, Guarino PD, Inzucchi SE, Stuart A, Young LH; Insulin Resistance Intervention After Stroke (IRIS) Trial Investigators. Targeting Pioglitazone Hydrochloride Therapy After Stroke or Transient Ischemic Attack According to Pretreatment Risk for Stroke or Myocardial Infarction. JAMA Neurol. 2017 Nov 1;74(11):1319-1327. doi: 10.1001/jamaneurol.2017.2136.

    PubMed 28975241

  • Stuart AC, Sico JJ, Viscoli CM, Tayal AH, Inzucchi SE, Ford GA, Furie KL, Cote R, Spence JD, Tanne D, Kernan WN. Taking care of volunteers in a stroke trial: a new assisted-management strategy. Stroke Vasc Neurol. 2016 Oct 25;1(3):108-114. doi: 10.1136/svn-2016-000029. eCollection 2016 Sep.

    PubMed 28959471

  • Furie KL, Viscoli CM, Gorman M, Ford GA, Young LH, Inzucchi SE, Guarino PD, Lovejoy AM, Conwit R, Tanne D, Kernan WN; IRIS Trial Investigators. Effects of pioglitazone on cognitive function in patients with a recent ischaemic stroke or TIA: a report from the IRIS trial. J Neurol Neurosurg Psychiatry. 2018 Jan;89(1):21-27. doi: 10.1136/jnnp-2017-316361. Epub 2017 Sep 22.

    PubMed 28939682

  • Young LH, Viscoli CM, Curtis JP, Inzucchi SE, Schwartz GG, Lovejoy AM, Furie KL, Gorman MJ, Conwit R, Abbott JD, Jacoby DL, Kolansky DM, Pfau SE, Ling FS, Kernan WN; IRIS Investigators. Cardiac Outcomes After Ischemic Stroke or Transient Ischemic Attack: Effects of Pioglitazone in Patients With Insulin Resistance Without Diabetes Mellitus. Circulation. 2017 May 16;135(20):1882-1893. doi: 10.1161/CIRCULATIONAHA.116.024863. Epub 2017 Feb 28.

    PubMed 28246237

  • Viscoli CM, Inzucchi SE, Young LH, Insogna KL, Conwit R, Furie KL, Gorman M, Kelly MA, Lovejoy AM, Kernan WN; IRIS Trial Investigators. Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial. J Clin Endocrinol Metab. 2017 Mar 1;102(3):914-922. doi: 10.1210/jc.2016-3237.

    PubMed 27935736

  • Inzucchi SE, Viscoli CM, Young LH, Furie KL, Gorman M, Lovejoy AM, Dagogo-Jack S, Ismail-Beigi F, Korytkowski MT, Pratley RE, Schwartz GG, Kernan WN; IRIS Trial Investigators. Pioglitazone Prevents Diabetes in Patients With Insulin Resistance and Cerebrovascular Disease. Diabetes Care. 2016 Oct;39(10):1684-92. doi: 10.2337/dc16-0798. Epub 2016 Jul 27.

    PubMed 27465265

  • Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP Jr, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR; IRIS Trial Investigators. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Apr 7;374(14):1321-31. doi: 10.1056/NEJMoa1506930. Epub 2016 Feb 17.

    PubMed 26886418

  • Kernan WN, Inzucchi SE. Metabolic rehabilitation: science gathers to support a new intervention to prevent stroke. Stroke. 2011 Dec;42(12):3333-5. doi: 10.1161/STROKEAHA.111.632489. Epub 2011 Oct 13. No abstract available.

    PubMed 21998067

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pioglitazone in people with Stroke and Myocardial Infarction, run by Yale University at 183 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, United Kingdom, Germany, Canada, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091949, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

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