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| Sponsor: | Yale University |
|---|---|
| Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Takeda Pharmaceuticals North America, Inc. |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00091949 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Myocardial Infarction Diabetes |
Drug: pioglitazone Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Insulin Resistance Intervention After Stroke (IRIS) Trial |
| Estimated Enrollment: | 3936 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
pioglitazone
|
Drug: pioglitazone
a thiazolidinedione drug
|
| Placebo Comparator: 2 |
Drug: placebo
an inactive substance
|
Among patients throughout the world who experience a transient ischemic attack (TIA)or 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 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 3936 subjects at approximately 170 hospitals in Australia, Canada, Germany, Israel, Italy, the 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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Permanent Exclusions
Irreversible medical conditions likely to affect short-term survival or ability to participate in the study protocol. These include:
Current participation in a conflicting clinical trial. A conflicting clinical trial is defined as a trial with any of following:
Temporary Exclusions Persons with temporary exclusions may be enrolled as soon as the exclusion has resolved.
Contacts and Locations| Contact: Walter N. Kernan, M.D. | 203-764-7000 |
Show 184 Study Locations| Principal Investigator: | Walter N. Kernan, M.D. | Yale University |
More Information
| Responsible Party: | Walter N. Kernan, MD, Principal Investigator, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00091949 History of Changes |
| Other Study ID Numbers: | R01NS044876, U01NS044876 |
| Study First Received: | September 20, 2004 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stroke heart attack diabetes pioglitazone insulin resistance |
|
Diabetes Mellitus Infarction Insulin Resistance Myocardial Infarction Stroke Cerebral Infarction Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Ischemia Pathologic Processes Necrosis Hyperinsulinism Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Brain Infarction Brain Ischemia Pioglitazone Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |