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	Treatment or Intervention	Phase
Stroke Myocardial Infarction Diabetes	Drug: pioglitazone	Phase III

Recurrent stroke and heart attack are major sources of illness and death among the 400,000 Americans who survive a stroke each year. Within 5 years of the initial stroke, 25 percent of patients will have a recurrent stroke, 17 percent will have a heart attack, and 6 percent will die from one of these 2 conditions. Therefore, prevention of further vascular events is important.

The Insulin Resistance Intervention After Stroke (IRIS) trial is a large, multi-center clinical study that proposes an innovative therapy based on 20 years of accumulating evidence linking insulin resistance to increased risk for stroke and other vascular diseases. IRIS will test the effectiveness of a new treatment called pioglitazone for preventing future strokes and heart attacks among non-diabetic persons who have had a recent ischemic stroke.

Pioglitazone is a medication that improves insulin resistance—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. Scientists believe that pioglitazone, by treating insulin resistance, may prevent stroke and heart attack.

This randomized, double-blind, placebo-controlled study will enroll 3136 subjects at approximately 100 hospitals to determine if pioglitazone, when compared to a placebo, will reduce the risk of recurrent stroke and heart attack in stroke patients. After an initial blood test screening, each participant will be randomly assigned to take either pioglitazone or placebo tablets. Recruitment will be completed in 3 years, and all participants will be followed for a minimum of 3 years.

Ages Eligible for Study:  45 Years and above,  Genders Eligible for Study:  Both

Criteria

To be eligible you must:

• Be 45 years old or older
• Be non-diabetic
• Have had a recent non-embolic ischemic stroke
• Be insulin resistant as determined by a special fasting blood test

Walter N. Kernan, M.D.      203-688-4545 

Connecticut
      Yale University, New Haven,  Connecticut,  06520,  United States

Study chairs or principal investigators

Walter N. Kernan, M.D.,  Principal Investigator,  Yale University   

Study ID Numbers:  R01NS044876
Record last reviewed:  September 2004
Record first received:  September 20, 2004
ClinicalTrials.gov Identifier:  NCT00091949
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27