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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00091949




Registration number
NCT00091949
Ethics application status
Date submitted
20/09/2004
Date registered
22/09/2004

Titles & IDs
Public title
Insulin Resistance Intervention After Stroke Trial
Scientific title
Insulin Resistance Intervention After Stroke (IRIS) Trial
Secondary ID [1] 0 0
5U01NS044876-10
Secondary ID [2] 0 0
0201013034
Universal Trial Number (UTN)
Trial acronym
IRIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Myocardial Infarction 0 0
Diabetes 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pioglitazone
Treatment: Drugs - placebo

Active comparator: Pioglitazone - pioglitazone

Placebo comparator: Placebo - inactive substance


Treatment: Drugs: pioglitazone
a thiazolidinedione drug

Treatment: Drugs: placebo
an inactive substance
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Fatal or Non-fatal Stroke Alone
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Acute Coronary Syndrome
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Development of Overt Diabetes
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
All Cause Mortality
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Decline in Cognitive Status
Timepoint [5] 0 0
Annual measures from baseline to exit (up to 5 years)
Secondary outcome [6] 0 0
Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure
Timepoint [6] 0 0
5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Ages 40 years or greater at the time of randomization.
2. Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization
3. Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity (HOMA).
4. Both ability and willingness to provide informed consent.
5. Presence of none of the exclusion criteria.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Permanent Exclusions

1. Severely disabling stroke as indicated by an inability to participate in scheduled follow-up activities.
2. Persons whose ischemic stroke or TIA was related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation.
3. 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.
4. HgbA1c > 7.0%.
5. 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).
6. History of intolerance to any thiazolidinedione.
7. Pregnancy or desire to become pregnant.
8. Oral contraceptive use.
9. Ongoing use of oral corticosteroids.
10. History of heart failure
11. 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.
12. History of bladder cancer.
13. 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.

1. Alanine aminotransferase (ALT) >2.5 times the upper limit of normal.
2. Hemoglobin <8.5 g/dl.
3. Moderate or severe pitting edema of the feet or legs (IRIS grade 3 or 4).
4. Carotid surgery or carotid stenting procedure scheduled (delay randomization until 2 weeks following procedure).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
3876
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Royal Prince Alfred - Camperstown
Recruitment hospital [3] 0 0
John Hunter Hospital (University of Newcastle) - New Lambton Heights
Recruitment hospital [4] 0 0
Box Hill Hospital (Eastern Health) - Box Hill
Recruitment hospital [5] 0 0
Western Hospital (University of Melbourne) - Footscray
Recruitment hospital [6] 0 0
Austin Health (National Stroke Research Institute) - Heidelberg Heights
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Royal Perth - Perth
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2050 - Camperstown
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3801 - Heidelberg Heights
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
Country [9] 0 0
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Michigan
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Mississippi
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Halle
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Heidelberg
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Jena
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Ulm
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Holon
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Petach Tikva
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Ramat Gan
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Roma
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Italy
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Rome
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Italy
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Vibo Valentia
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San Juan
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Dorset
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Kent
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Northumberland
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Scotland
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Tyne And Wear
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Aberdeen
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Airdrie
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Ashford
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Bath
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Cambridge
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Cheshire
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Dewsbury
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Essex
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Exeter
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Guildford
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Halifax
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Liverpool
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London
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Luton
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Middlesbrough
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Newcastle upon Tyne
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United Kingdom
State/province [98] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Other
Name
Yale University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Takeda Pharmaceuticals North America, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Walter N. Kernan, M.D.
Address 0 0
Yale University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00091949