The Insulin Resistance Intervention after Stroke (IRIS) trial
Research type
Research Study
Full title
The Insulin Resistance Intervention after Stroke Trial: A randomized, placebo-controlled trial of pioglitazone, compared with placebo, for prevention of stroke and myocardial infarction after ischemic stroke and transient ischemic attack
IRAS ID
3708
Contact name
Gary A Ford
Sponsor organisation
Dr Walter Kernan (as CI at study coordinating centre, is sponsor of the IND)
Eudract number
2008-005546-23
Clinicaltrials.gov Identifier
Research summary
This research study is trying to find out if a medication called pioglitazone is effective in preventing future strokes and heart attacks in insulin-resistant persons who have had a recent stroke or transient ischemic attack (TIA). ??Insulin resistance? is a common condition that can lead to diabetes. Eligible patients for the IRIS trial are non-diabetic men and women age 40 years or older who have had a recent stroke or transient ischaemic attack (TIA or 'mini-stroke'). The IRIS trial is based on research showing that insulin resistance is associated with increased risk for stroke and heart disease. By improving insulin resistance, pioglitazone has been shown to potentially reduce this risk in patients with diabetes. The IRIS study will test if pioglitazone has a similar benefit in people with a stroke or TIA who do not have diabetes. Patients will be randomised (allocated by chance) to receive either pioglitazone (15mg per day, rising to 45 mg per day) or an identical placebo for a minimum of 3 years and a max (in UK) of 4 years. They will be followed up over that period of time, to see whether those on pioglitazone have a reduced overall risk for fatal or non-fatal stroke or fatal or non-fatal myocardial infarction (MI, commonly known as 'heart attack'), or progression to overt diabetes.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
09/H0505/70
Date of REC Opinion
17 Jun 2009
REC opinion
Further Information Favourable Opinion