At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,876 enrolled
Drug / intervention
pioglitazone +1 moredrug
Likely dose
pioglitazone dosing not specified in the published trial recordAI-extracted
Key inclusion· 3
- ✓Age ≥40 years at randomization
- ✓Ischemic stroke or TIA occurring 14 days to 6 months before randomization
- ✓Insulin resistance documented by HOMA >3.0
Key exclusion· 10
- ✕Diabetes mellitus (on diabetes medication or fasting glucose >126 mg/dL twice)
- ✕HbA1c >7.0%
- ✕History of heart failure
- ✕Active liver disease with cirrhosis, cholestasis, portal hypertension, hepatic encephalopathy, or synthetic dysfunction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Insulin Resistance Intervention After Stroke (IRIS) Trial
In Brief
A Phase 3 clinical trial evaluating pioglitazone and placebo for Stroke and 2 related conditions. Completed, enrolled 3,876 participants across 183 sites in 8 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Myocardial Infarction, Diabetes
CountriesAustralia, Canada, Germany, Israel, Italy, Puerto Rico, United Kingdom, United States
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2004
Enrollment StartFeb 2005
Primary CompletionNov 2015
TodayJul 2026
First PostedSep 22, 2004
Enrollment StartFeb 1, 2005
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 21.8 years ago
Interventions
pioglitazonedrug
a thiazolidinedione drug
placebodrug
an inactive substance