Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091949
Status:
COMPLETED
Last Update Posted:
2020-04-27
First Post:
2004-09-20
Brief Title:
Insulin Resistance Intervention After Stroke Trial
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Insulin Resistance Intervention After Stroke IRIS Trial
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRIS
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:
Among patients throughout the world who experience a transient ischemic attack TIAor ischemic stroke subsequent stroke and heart attack are major causes of death and disability Within 4 years of the initial TIA or ischemic 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 TZD drugs 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 3936 subjects at approximately 170 hospitals in Australia Canada Germany Israel Italy the United Kingdom UK and the US After an initial screening blood test each participant will be randomly assigned to take either pioglitazone or placebo tablets Recruitment will be completed during 2005-2012 and all participants will be followed for a minimum of 3 years
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 TZD drugs 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 3936 subjects at approximately 170 hospitals in Australia Canada Germany Israel Italy the United Kingdom UK and the US After an initial screening blood test each participant will be randomly assigned to take either pioglitazone or placebo tablets Recruitment will be completed during 2005-2012 and all participants will be followed for a minimum of 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01NS044876-10 | NIH | None | httpsreporternihgovquickSearch5U01NS044876-10 |