Gregory W. Albers
The Insulin Resistance Intervention after Stroke Trial (IRIS)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Pioglitazone is an agent that reduces insulin resistance and improves the risk of atherosclerotic events. The IRIS study proposes an innovative therapy based on 20 years of collecting evidence linking insulin resistance to increased risk for stroke and other vascular diseases. The primary aim is to determine if pioglitazone is effective in lowering the risk for stroke or MI among non-diabetic men and women 45 years or older with insulin resistance and a recent ischemic stroke. Since insulin resistance is estimated in approximately 50% of stroke pateints, this innovative strategy has the potential to benefit a large number of patients.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: pioglitizone vs placebo
Phase:
Phase 2Eligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
a. Ages 40 years or greater at the time of randomization.
b. Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization
c. Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model
Assessment of insulin sensitivity.
d. Both ability and willingness to provide informed consent.
e. Presence of none of the exclusion criteria.
Key Exclusion Criteria:
We will identify two distinct types of exclusions, permanent and temporary.
Permanent Exclusions
a. Severely disabling stroke as indicated by inability to stand on a scale with assistance and
participate in scheduled follow-up activities.
b. Persons whose ischemic stroke or TIA was related to structural cardiac lesion, significant head
trauma, proximal arterial dissection or medical instrumentation.
c. 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.
d. HgbA1c > 7.0%.
e. 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).
f. History of intolerance to any thiazolidinedione.
g. Pregnancy or desire to become pregnant.
h. Oral contraceptive use.
i. Ongoing use of oral corticosteroids.
j. Congestive heart failure NYHA Class 2 or higher within the past 3 months.
k. Active liver disease as defined by known liver disease accompanied by cirrhosis, significant
cholestasis, portal hypertension, encephalopathy, hepatic synthetic dysfunction, or expected
significant loss of liver function over the course of the study.
l. History of bladder cancer.
m. 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.
a. ALT >2.5 times the upper limit of normal.
b. Hemoglobin <8.5 g/dl.
c. Marked pitting edema of the feet and legs (IRIS grade 3 or 4).
d. Carotid surgery or carotid stenting procedure scheduled (delay randomization until 2 weeks
following procedure).
*Patients who have taken a medication to treat diabetes in the prior 3 months as an out-patient will not be
eligible for participation. However, a patient who has recently taken a diabetes medication while
hospitalized or for a reason other than diabetes (e.g., for impaired glucose tolerance), may be tested for
eligibility after at least 7 days off the medication.
Additional Study Details
Official Title:
A randomized, placebo-controlled trial of pioglitazone, compared with placebo, for prevention of recurrent stroke and myocardial infarction after ischemic strokeAnticipated start date:
7/1/2007Lead Sponsor:
Yale UniversityInvestigator(s):
- Maarten G Lansberg MD, PhD
- Gregory W Albers
- Neil Schwartz
- Christine Wijman
- Anna K. Finley Caulfield
- Dr. chitra venkat
- Archana Purushotham
- Edgar Samaniego
- Mikayel Grigoryan
- Duane Omar Campbell
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- recurrent stroke
- myocardial infarction
Secondary Outcomes:
- acute coronary syndrome/unstable angina
- diabetes
- all cause mortality
- cognitive decline
Total Number to be Enrolled:
3136Total Number to be Enrolled at Stanford:
30More Information
Secondary ID(s):
- 1RO1 NS 44876-01A2
- 5697
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/11/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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