Phase 3
Completed N=3,876
Insulin Resistance Intervention After Stroke Trial
Source: ClinicalTrials.gov NCT00091949 ↗Enrolled (actual)
3,876
Serious AEs
50.0%
Results posted
Oct 2016
Primary outcomePrimary: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction — 175; 228 participants — p=.0067
◆ Published Evidence
Highly cited
108citations · ~15 / year
Pioglitazone Therapy in Patients With Stroke and Prediabetes: A Post Hoc Analysis of the IRIS Randomized Clinical Trial.
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.
Linked Publications (5)
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Pioglitazone Therapy in Patients With Stroke and Prediabetes: A Post Hoc Analysis of the IRIS Randomized Clinical Trial.
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Pioglitazone Prevents Stroke in Patients With a Recent Transient Ischemic Attack or Ischemic Stroke: A Planned Secondary Analysis of the IRIS Trial (Insulin Resistance Intervention After Stroke).
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Heart Failure After Ischemic Stroke or Transient Ischemic Attack in Insulin-Resistant Patients Without Diabetes Mellitus Treated With Pioglitazone.
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Targeting Pioglitazone Hydrochloride Therapy After Stroke or Transient Ischemic Attack According to Pretreatment Risk for Stroke or Myocardial Infarction.
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Silent Myocardial Infarction and Risk of Stroke Recurrence: A Post Hoc Analysis of the IRIS Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction |
175; 228 | .0067 sig |
| SECONDARY Fatal or Non-fatal Stroke Alone |
127; 154 | 0.19 |
| SECONDARY Acute Coronary Syndrome |
206; 249 | 0.11 |
| SECONDARY Development of Overt Diabetes |
73; 149 | — |
| SECONDARY All Cause Mortality |
136; 146 | 0.52 |
| SECONDARY Decline in Cognitive Status |
0.27; 0.29 | 0.88 |
| SECONDARY Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure |
206; 249 | 0.11 |
Eligibility Criteria
Inclusion Criteria
- Ages 40 years or greater at the time of randomization.
- Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization
- Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity (HOMA).
- Both ability and willingness to provide informed consent.
- Presence of none of the exclusion criteria.
Exclusion Criteria
Permanent Exclusions
- Severely disabling stroke as indicated by an inability to participate in scheduled follow-up activities.
- Persons whose ischemic stroke or TIA was related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation.
- 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.
- HgbA1c > 7.0%.
- 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).
- History of intolerance to any thiazolidinedione.
- Pregnancy or desire to become pregnant.
- Oral contraceptive use.
- Ongoing use of oral corticosteroids.
- History of heart failure
- 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.
- History of bladder cancer.
- 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.
- Alanine aminotransferase (ALT) >2.5 times the upper limit of normal.
- Hemoglobin <8.5 g/dl.
- Moderate or severe pitting edema of the feet or legs (IRIS grade 3 or 4).
- Carotid surgery or carotid stenting procedure scheduled (delay randomization until 2 weeks following procedure).
Data sourced from ClinicalTrials.gov (NCT00091949) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.