Trial · NCT00091949
Insulin Resistance Intervention After Stroke Trial
NCT00091949, Phase 3, Completed, Yale University; results first posted 2016-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Insulin Resistance Intervention After Stroke Trial. Trials, record NCT00091949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00091949
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Insulin Resistance Intervention After Stroke Trial
- NCT number
- NCT00091949
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,876 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Stroke, Myocardial Infarction, Diabetes
- Interventions
- pioglitazone, placebo
- First posted
- 2004-09-22
- Last updated
- 2020-04-27
- Results first posted
- 2016-10-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction | Up to 5 years | |
| Secondary | Fatal or Non-fatal Stroke Alone | 5 years | |
| Secondary | Acute Coronary Syndrome | 5 years | Fatal or non-fatal acute myocardial infarction or unstable angina |
| Secondary | Development of Overt Diabetes | 5 years | |
| Secondary | All Cause Mortality | 5 years | |
| Secondary | Decline in Cognitive Status | Annual measures from baseline to exit (up to 5 years) | Change in modified mental status examination (3MS) score from baseline to exit. Theoretical range of 3MS scores is 0-100. Baseline scores ranged from 22-100. |
| Secondary | Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure | 5 years |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction | Up to 5 years | participants | NUMBER | |
| SECONDARY | Fatal or Non-fatal Stroke Alone | 5 years | participants | NUMBER | |
| SECONDARY | Acute Coronary Syndrome | 5 years | participants | NUMBER | |
| SECONDARY | Development of Overt Diabetes | 5 years | participants | NUMBER | |
| SECONDARY | All Cause Mortality | 5 years | participants | NUMBER | |
| SECONDARY | Decline in Cognitive Status | Annual measures from baseline to exit (up to 5 years) | Participants with baseline and at least 1 follow-up modified mini-mental examination score. | units on a scale | MEAN |
| SECONDARY | Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure | 5 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction | Pioglitazone | 175 | participants | ||
| Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction | Placebo | 228 | participants | ||
| Fatal or Non-fatal Stroke Alone | Pioglitazone | 127 | participants | ||
| Fatal or Non-fatal Stroke Alone | Placebo | 154 | participants | ||
| Acute Coronary Syndrome | Pioglitazone | 206 | participants | ||
| Acute Coronary Syndrome | Placebo | 249 | participants | ||
| Development of Overt Diabetes | Pioglitazone | 73 | participants | ||
| Development of Overt Diabetes | Placebo | 149 | participants | ||
| All Cause Mortality | Pioglitazone | 136 | participants | ||
| All Cause Mortality | Placebo | 146 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pioglitazone | 1,939 | |
| Overall Study | STARTED | Placebo | 1,937 | |
| Overall Study | COMPLETED | Pioglitazone | 1,764 | |
| Overall Study | COMPLETED | Placebo | 1,786 | |
| Overall Study | NOT COMPLETED | Pioglitazone | 175 | |
| Overall Study | NOT COMPLETED | Placebo | 151 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bone fracture | General disorders | Pioglitazone | 133 | 1,939 | 198 |
| other | Bone fracture | General disorders | Placebo | 94 | 1,937 | 126 |
| other | Excessive weight gain | General disorders | Pioglitazone | 221 | 1,939 | 892 |
| other | Excessive weight gain | General disorders | Placebo | 88 | 1,937 | 305 |
| other | Edema | General disorders | Pioglitazone | 691 | 1,939 | 1,093 |
| other | Edema | General disorders | Placebo | 483 | 1,937 | 731 |
| other | Shortness of breath | General disorders | Pioglitazone | 342 | 1,939 | 444 |
| other | Shortness of breath | General disorders | Placebo | 292 | 1,937 | 379 |
| serious | Hospitalization | General disorders | Pioglitazone | 908 | 1,939 | 1,844 |
| serious | Hospitalization | General disorders | Placebo | 946 | 1,937 | 2,023 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pioglitazone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pioglitazone | 1,007 | 1,939 |
| Total, other adverse events | Placebo | 724 | 1,937 |
| Total, serious adverse events | Pioglitazone | 950 | 1,939 |
| Total, serious adverse events | Placebo | 987 | 1,937 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS044876 | Insulin Resistance Intervention after Stroke (IRIS) Trial | KERNAN, WALTER N | YALE UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2004 to 2013 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pioglitazone vs Placebo: Acute Coronary Syndrome | Trial comparisons |
| Pioglitazone vs Placebo: Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure | Trial comparisons |
| Pioglitazone vs Placebo: Fatal or Non-fatal Stroke Alone | Trial comparisons |
| Pioglitazone vs Placebo: All Cause Mortality | Trial comparisons |
| Pioglitazone vs Placebo: Development of Overt Diabetes | Trial comparisons |
| Pioglitazone vs Placebo: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction | Trial comparisons |
| Pioglitazone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00091949
GET https://conductscience.org/api/trials/v1/NCT00091949/registered