Insulin Resistance Intervention After Stroke Trial - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 20, 2004

Last Updated Date

December 11, 2008

Start Date ^†

February 2005

Current Primary Outcome Measures ^†

Time to occurrence of recurrent fatal or non-fatal stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
fatal or non-fatal myocardial infarction. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Time to occurrence of recurrent fatal or non-fatal stroke
or fatal or non-fatal myocardial infarction.

Change History

Complete list of historical versions of study NCT00091949 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

1.time to stroke alone; 2.Diabetes Mellitus; 3.All Cause Mortality; 4.Cognitive Decline (change in score over time for the Modified Mini Mental State Examination) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
stroke, MI, or congestive heart failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

1.Acute Coronary Syndrome/Unstable Angina; 2.Diabetes Mellitus; 3.All Cause Mortality; 4.Cognitive Decline (change in score over time for the Modified Mini Mental State Examination)

Descriptive Information

Brief Title ^†

Insulin Resistance Intervention After Stroke Trial

Official Title ^†

Insulin Resistance Intervention After Stroke (IRIS) Trial

Brief 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.

Detailed Description

Recurrent stroke and heart attack are major sources of illness and death among the 400,000 Americans who survive a stroke each year. Within 4 years of the initial stroke, 16 percent of patients will have a recurrent stroke and 9 percent will have a heart attack. Prevention of further vascular events, therefore, is critically important to the health of patients with stroke.

The IRIS trial will test a new treatment strategy based on evidence linking insulin resistance to increased risk for stroke and other vascular diseases.

Insulin resistance is 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.

Insulin resistance affects up to 50% of stroke patients and is effectively modified with thiazolidinedione drugs (called "TZDs") used to treat type 2 diabetes. In addition to reducing insulin resistance, these drugs have other favorable effects on blood vessels, reduce blood vessel inflammation, and potentially prevent atherosclerosis. Currently marketed TZDs include rosiglitazone and pioglitazone.

The IRIS is a clinical trial that will enroll 3136 subjects at approximately 100 hospitals in the US and Canada. After an initial screening blood test, 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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Stroke
Myocardial Infarction
Diabetes

Intervention ^†

Drug: pioglitazone
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: pioglitazone

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

3136

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

To be eligible you must:

Be 40 years and older
Be non-diabetic
Have a recent transient ischemic attack or stroke
Be insulin resistant as determined by a special fasting blood test

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Walter N. Kernan, M.D.

203-764-7000

Location Countries ^†

United States, Canada, Israel, Puerto Rico

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00091949

Responsible Party

Walter N. Kernan, MD, Principal Investigator, Yale University School of Medicine

Secondary IDs ^††

CRC

Study Sponsor ^†

Yale University

Collaborators ^††

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^†

Principal Investigator:

Walter N. Kernan, M.D.

Yale University

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.