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Am Heart J. 2014 Dec;168(6):823-9.e6. doi: 10.1016/j.ahj.2014.07.016. Epub 2014 Jul 28.

Pioglitazone for secondary prevention after ischemic stroke and transient ischemic attack: rationale and design of the Insulin Resistance Intervention after Stroke Trial.

Author information

1
Yale University School of Medicine, New Haven, CT. Electronic address: catherine.viscoli@yale.edu.
2
Yale University School of Medicine, New Haven, CT.
3
University of L'Aquila, L'Aquila, Italy.
4
National Institute of Neurological Disorders and Stroke, Bethesda, MD.
5
Oxford University, Oxford, United Kingdom.
6
Alpert Medical School of Brown University, Providence, RI.
7
University of Vermont School of Medicine, Burlington, VT.
8
Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT; Yale School of Public Health, New Haven, CT.
9
University of Newcastle, Newcastle, Australia.
10
University of Heidelberg, Heidelberg, Germany.
11
VA Medical Center and University of Colorado School of Medicine, Denver, CO.
12
University of Western Ontario, London, Ontario, Canada.
13
Tel Aviv University, Tel Aviv, Israel.

Abstract

BACKGROUND:

Recurrent vascular events remain a major source of morbidity and mortality after stroke or transient ischemic attack (TIA). The IRIS Trial is evaluating an approach to secondary prevention based on the established association between insulin resistance and increased risk for ischemic vascular events. Specifically, IRIS will test the effectiveness of pioglitazone, an insulin-sensitizing drug of the thiazolidinedione class, for reducing the risk for stroke and myocardial infarction (MI) among insulin resistant, nondiabetic patients with a recent ischemic stroke or TIA.

DESIGN:

Eligible patients for IRIS must have had insulin resistance defined by a Homeostasis Model Assessment-Insulin Resistance > 3.0 without meeting criteria for diabetes. Within 6 months of the index stroke or TIA, patients were randomly assigned to pioglitazone (titrated from 15 to 45 mg/d) or matching placebo and followed for up to 5 years. The primary outcome is time to stroke or MI. Secondary outcomes include time to stroke alone, acute coronary syndrome, diabetes, cognitive decline, and all-cause mortality. Enrollment of 3,876 participants from 179 sites in 7 countries was completed in January 2013. Participant follow-up will continue until July 2015.

SUMMARY:

The IRIS Trial will determine whether treatment with pioglitazone improves cardiovascular outcomes of nondiabetic, insulin-resistant patients with stroke or TIA. Results are expected in early 2016.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00091949.

PMID:
25458644
PMCID:
PMC4254508
DOI:
10.1016/j.ahj.2014.07.016
[Indexed for MEDLINE]
Free PMC Article

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