Insulin Resistance Intervention After Stroke Trial (IRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091949
Recruitment Status : Completed
First Posted : September 22, 2004
Results First Posted : October 28, 2016
Last Update Posted : October 28, 2016
National Institute of Neurological Disorders and Stroke (NINDS)
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Myocardial Infarction
Interventions: Drug: pioglitazone
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Pioglitazone pioglitazone: a thiazolidinedione drug
Placebo placebo: an inactive substance

Participant Flow:   Overall Study
    Pioglitazone   Placebo
STARTED   1939   1937 
COMPLETED   1764   1786 
NOT COMPLETED   175   151 
Withdrawal by Subject                117                110 
Lost to Follow-up                58                41 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Pioglitazone pioglitazone: a thiazolidinedione drug
Placebo placebo: an inactive substance
Total Total of all reporting groups

Baseline Measures
   Pioglitazone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1939   1937   3876 
[Units: Years]
Mean (Standard Deviation)
 63.5  (10.7)   63.5  (10.6)   63.5  (10.7) 
[Units: Participants]
Female   646   692   1338 
Male   1293   1245   2538 
Region of Enrollment 
[Units: Participants]
Canada   272   271   543 
Puerto Rico   9   11   20 
United States   1296   1276   2572 
United Kingdom   123   133   256 
Italy   22   26   48 
Israel   90   88   178 
Australia   53   55   108 
Germany   74   77   151 

  Outcome Measures

1.  Primary:   Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction   [ Time Frame: Up to 5 years ]

2.  Secondary:   Fatal or Non-fatal Stroke Alone   [ Time Frame: 5 years ]

3.  Secondary:   Acute Coronary Syndrome   [ Time Frame: 5 years ]

4.  Secondary:   Development of Overt Diabetes   [ Time Frame: 5 years ]

5.  Secondary:   All Cause Mortality   [ Time Frame: 5 years ]

6.  Secondary:   Decline in Cognitive Status   [ Time Frame: Annual measures from baseline to exit (up to 5 years) ]

7.  Secondary:   Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure   [ Time Frame: 5 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Walter N. Kernan
Organization: Yale School of Medicine
phone: 203-764-7000

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Yale University Identifier: NCT00091949     History of Changes
Other Study ID Numbers: R01NS044876
U01NS044876 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2004
First Posted: September 22, 2004
Results First Submitted: July 19, 2016
Results First Posted: October 28, 2016
Last Update Posted: October 28, 2016