Insulin Resistance Intervention After Stroke Trial

Not Recruiting

Trial ID: NCT00091949


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.

Official Title

Insulin Resistance Intervention After Stroke (IRIS) Trial

Stanford Investigator(s)

Maarten Lansberg, MD, PhD
Maarten Lansberg, MD, PhD

Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Anna Finley Caulfield, MD
Anna Finley Caulfield, MD

Clinical Professor, Neurology & Neurological Sciences

Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Gregory W. Albers, MD
Gregory W. Albers, MD

Coyote Foundation Professor and Professor, by courtesy, of Neurosurgery


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

   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

      - 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. Alanine aminotransferase (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).


drug: pioglitazone

drug: placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Madelleine Garcia