Trial Outcomes & Findings for Insulin Resistance Intervention After Stroke Trial (NCT NCT00091949)

NCT ID: NCT00091949

Last Updated: 2020-04-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3876 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2020-04-27

Participant Flow

Participant milestones

Measure	Pioglitazone pioglitazone: a thiazolidinedione drug	Placebo placebo: an inactive substance
Overall Study STARTED	1939	1937
Overall Study COMPLETED	1764	1786
Overall Study NOT COMPLETED	175	151

Reasons for withdrawal

Measure	Pioglitazone pioglitazone: a thiazolidinedione drug	Placebo placebo: an inactive substance
Overall Study Withdrawal by Subject	117	110
Overall Study Lost to Follow-up	58	41

Baseline Characteristics

Insulin Resistance Intervention After Stroke Trial

Baseline characteristics by cohort

Measure	Pioglitazone n=1939 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1937 Participants placebo: an inactive substance	Total n=3876 Participants Total of all reporting groups
Age, Continuous	63.5 Years STANDARD_DEVIATION 10.7 • n=5 Participants	63.5 Years STANDARD_DEVIATION 10.6 • n=7 Participants	63.5 Years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	646 Participants n=5 Participants	692 Participants n=7 Participants	1338 Participants n=5 Participants
Sex: Female, Male Male	1293 Participants n=5 Participants	1245 Participants n=7 Participants	2538 Participants n=5 Participants
Region of Enrollment Canada	272 participants n=5 Participants	271 participants n=7 Participants	543 participants n=5 Participants
Region of Enrollment Puerto Rico	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment United States	1296 participants n=5 Participants	1276 participants n=7 Participants	2572 participants n=5 Participants
Region of Enrollment United Kingdom	123 participants n=5 Participants	133 participants n=7 Participants	256 participants n=5 Participants
Region of Enrollment Italy	22 participants n=5 Participants	26 participants n=7 Participants	48 participants n=5 Participants
Region of Enrollment Israel	90 participants n=5 Participants	88 participants n=7 Participants	178 participants n=5 Participants
Region of Enrollment Australia	53 participants n=5 Participants	55 participants n=7 Participants	108 participants n=5 Participants
Region of Enrollment Germany	74 participants n=5 Participants	77 participants n=7 Participants	151 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Measure	Pioglitazone n=1939 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1937 Participants placebo: an inactive substance
Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction	175 participants	228 participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	Pioglitazone n=1939 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1937 Participants placebo: an inactive substance
Fatal or Non-fatal Stroke Alone	127 participants	154 participants

SECONDARY outcome

Timeframe: 5 years

Fatal or non-fatal acute myocardial infarction or unstable angina

Outcome measures

Measure	Pioglitazone n=1939 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1937 Participants placebo: an inactive substance
Acute Coronary Syndrome	206 participants	249 participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	Pioglitazone n=1939 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1937 Participants placebo: an inactive substance
Development of Overt Diabetes	73 participants	149 participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	Pioglitazone n=1939 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1937 Participants placebo: an inactive substance
All Cause Mortality	136 participants	146 participants

SECONDARY outcome

Timeframe: Annual measures from baseline to exit (up to 5 years)

Population: Participants with baseline and at least 1 follow-up modified mini-mental examination score.

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.

Outcome measures

Measure	Pioglitazone n=1699 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1699 Participants placebo: an inactive substance
Decline in Cognitive Status	0.27 units on a scale Standard Error 0.13	0.29 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	Pioglitazone n=1939 Participants pioglitazone: a thiazolidinedione drug	Placebo n=1937 Participants placebo: an inactive substance
Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure	206 participants	249 participants

Adverse Events

Pioglitazone

Serious events: 950 serious events

Other events: 1007 other events

Deaths: 0 deaths

Placebo

Serious events: 987 serious events

Other events: 724 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pioglitazone n=1939 participants at risk pioglitazone: a thiazolidinedione drug	Placebo n=1937 participants at risk placebo: an inactive substance
General disorders Hospitalization	46.8% 908/1939 • Number of events 1844 • Adverse event data collected during followup (2 to 5 years).	48.8% 946/1937 • Number of events 2023 • Adverse event data collected during followup (2 to 5 years).
Cardiac disorders Heart failure	2.6% 51/1939 • Number of events 61 • Adverse event data collected during followup (2 to 5 years).	2.2% 42/1937 • Number of events 55 • Adverse event data collected during followup (2 to 5 years).
General disorders Cancer	6.9% 133/1939 • Number of events 144 • Adverse event data collected during followup (2 to 5 years).	7.7% 150/1937 • Number of events 163 • Adverse event data collected during followup (2 to 5 years).
General disorders Bone fracture	5.1% 99/1939 • Number of events 178 • Adverse event data collected during followup (2 to 5 years).	3.2% 62/1937 • Number of events 99 • Adverse event data collected during followup (2 to 5 years).

Other adverse events

Measure	Pioglitazone n=1939 participants at risk pioglitazone: a thiazolidinedione drug	Placebo n=1937 participants at risk placebo: an inactive substance
General disorders Bone fracture	6.9% 133/1939 • Number of events 198 • Adverse event data collected during followup (2 to 5 years).	4.9% 94/1937 • Number of events 126 • Adverse event data collected during followup (2 to 5 years).
General disorders Excessive weight gain	11.4% 221/1939 • Number of events 892 • Adverse event data collected during followup (2 to 5 years).	4.5% 88/1937 • Number of events 305 • Adverse event data collected during followup (2 to 5 years).
General disorders Edema	35.6% 691/1939 • Number of events 1093 • Adverse event data collected during followup (2 to 5 years).	24.9% 483/1937 • Number of events 731 • Adverse event data collected during followup (2 to 5 years).
General disorders Shortness of breath	17.6% 342/1939 • Number of events 444 • Adverse event data collected during followup (2 to 5 years).	15.1% 292/1937 • Number of events 379 • Adverse event data collected during followup (2 to 5 years).

Additional Information

Walter N. Kernan

Yale School of Medicine

Phone: 203-764-7000

Email: walter.kernan@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place