Insulin Resistance Intervention After Stroke Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Stroke, Myocardial Infarction, Diabetes

In brief

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.

Key facts

Study ID

NCT00091949

Run by

Yale University

People needed

3876

Starts

2005-02-01

Expected to finish

2015-11-01

Last updated by the study team

2020-04-27

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• Shanti Clinical Trials (NINDS-CRC site) — Colton, California, United States
• UCSF-Fresno — Fresno, California, United States
• Scripps Clinic — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California-Davis — Sacramento, California, United States
• University of California — San Diego, California, United States
• University of California — San Francisco, California, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• Hartford — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• National Rehabilitation Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• MIMA Century Research Associates — Melbourne, Florida, United States
• Pines Neurological Associates (NINDS-CRC site) — Pembroke Pines, Florida, United States
• Floria Neurovascular Institute — Tampa, Florida, United States
• Cook County (Stroger) Hospital — Chicago, Illinois, United States
• Rush University — Chicago, Illinois, United States
• University of Illinois — Chicago, Illinois, United States
• Ingalls Memorial Hospital (NINDS-CRC site) — Harvey, Illinois, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.