Trial Outcomes & Findings for Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke (NCT NCT04123067)

NCT ID: NCT04123067

Last Updated: 2022-09-15

Results Overview

NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

90 days post stroke

Results posted on

2022-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Pioglitazone Treatment Group oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset Pioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset	Placebo Group Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset Placebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pioglitazone Treatment Group oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset Pioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset	Placebo Group Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset Placebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone Treatment Group oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset Pioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset	Placebo Group n=1 Participants Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset Placebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset	Total n=1 Participants Total of all reporting groups
Age, Continuous	—	72 years STANDARD_DEVIATION 0 • n=7 Participants	72 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days post stroke

Population: Subject that received Placebo was lost to follow up and 90 day outcome data was not collected.

NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 90 days post stroke

Population: Subject that received Placebo was lost to follow up and 90 day outcome data was not collected.

Measured using the modified Rankin Scale (0-6) to assess neurological function with a score of 0 for no neurological deficits and a maximum of 6 for an expired patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours, 48 hours, and 90 days post-stroke

Population: Subject that received Placebo was lost to follow up and data was not collected for any time point

measured in blood by flow cytometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours, 48 hours, and 90 days poststroke

Population: Subject that received Placebo was lost to follow up and data was not collected for any time point.

measured in blood

Outcome measures

Outcome data not reported

Adverse Events

Pioglitazone Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kerstin Bettermann

Penn State Hershey Medical Center

Phone: 717-531-1803

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place