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Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

Primary Purpose

Stroke, Acute, Hyperglycemia, Diabetes

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pioglitazone 45 mg

Placebo oral tablet

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Stroke Patients ages 21 and over
Blood sugar ≥ 150 mg/dl
Study drug treatment should be initiated within 12 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown)
MRI or CT proven ischemic stroke
Initial NIH SS of ≥ 2
Willing and able to provide consent

Exclusion Criteria:

Known hypersensitivity to PGZ.
Infection at the time of presentation as defined by body temperature > 38 degrees C , pneumonia evident on chest X-ray, urinary tract infection (positive tests for nitrites, leukocyte esterase, and bacteria on urine analysis), other acute infection per history or current use of antibiotic or antiviral treatment.
Active malignancy and / or autoimmune disease requiring treatment.
Use of immunomodulatory drugs or chemotherapy.
History of stroke or brain injury within the last 90 days prior to presentation.
Acute illness within the last 30 days which could have affected the white blood cell count.
Known history of clinically significant hypoglycemia.
Patients already taking PGZ.
Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin > 1.2 mg/dl).
Acute decompensated heart failure, and/or admission for an acute coronary syndrome, myocardial infarction (MI), cardiac arrest, coronary artery surgery within the past 3 months and patients with New York Heart association Class III and IV heart failure.
History of bladder cancer
Pregnant and nursing women.
Currently incarcerated patients.

Sites / Locations

Penn State College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pioglitazone treatment group

Placebo group

Arm Description

oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset

Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset

Outcomes

Primary Outcome Measures

Neurological Status

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

Degree of Disability or Dependence in the Daily Activities

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

Secondary Outcome Measures

Concentration of Markers of Neutrophil Activation and Function

measured in blood by flow cytometry

Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine

measured in blood

Full Information

NCT ID

NCT04123067

First Posted

October 8, 2019

Last Updated

August 23, 2022

Sponsor

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04123067

Brief Title

Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

Official Title

Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Temporarily suspended due to Pandemic.

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

April 7, 2021 (Actual)

Study Completion Date

April 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Study objective is to determine whether Pioglitazone (PGZ) can improve clinical outcomes in hyperglycemic acute ischemic stroke (IS). The rationale for the proposed research is to develop an acute intervention that can improve neurological recovery and decrease mortality and morbidity in high-risk diabetic stroke patients.

Detailed Description

This is a prospective, randomized, double blinded stroke intervention study. Patients presenting with hyperglycemia (blood glucose level = or > than 150mg/dl) and acute stroke symptoms within 12h of onset will be randomized to either treatment with PGZ or placebo. Patients will receive oral drug vs placebo once daily for three consecutive days. Blood samples will be obtained at baseline and during the subsequent three days to collect various biomarkers of the stress-immune response following ischemic stroke. Clinical outcomes (NIH-SS and mRS) will be determined at 3 months. Secondary outcome measures are changes in the various blood biomarkers comparing both study groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute, Hyperglycemia, Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pioglitazone treatment group

Arm Type

Experimental

Arm Description

oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset

Intervention Type

Drug

Intervention Name(s)

Pioglitazone 45 mg

Intervention Description

45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

placebo daily for three subsequent days, initiated within 12h of stroke symptom onset

Primary Outcome Measure Information:

Title

Neurological Status

Description

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

Time Frame

90 days post stroke

Title

Degree of Disability or Dependence in the Daily Activities

Description

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

Time Frame

90 days post stroke

Secondary Outcome Measure Information:

Title

Concentration of Markers of Neutrophil Activation and Function

Description

measured in blood by flow cytometry

Time Frame

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

Title

Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine

Description

measured in blood

Time Frame

24 hours, 48 hours, and 90 days poststroke

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stroke Patients ages 21 and over Blood sugar ≥ 150 mg/dl Study drug treatment should be initiated within 12 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown) MRI or CT proven ischemic stroke Initial NIH SS of ≥ 2 Willing and able to provide consent Exclusion Criteria: Known hypersensitivity to PGZ. Infection at the time of presentation as defined by body temperature > 38 degrees C , pneumonia evident on chest X-ray, urinary tract infection (positive tests for nitrites, leukocyte esterase, and bacteria on urine analysis), other acute infection per history or current use of antibiotic or antiviral treatment. Active malignancy and / or autoimmune disease requiring treatment. Use of immunomodulatory drugs or chemotherapy. History of stroke or brain injury within the last 90 days prior to presentation. Acute illness within the last 30 days which could have affected the white blood cell count. Known history of clinically significant hypoglycemia. Patients already taking PGZ. Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin > 1.2 mg/dl). Acute decompensated heart failure, and/or admission for an acute coronary syndrome, myocardial infarction (MI), cardiac arrest, coronary artery surgery within the past 3 months and patients with New York Heart association Class III and IV heart failure. History of bladder cancer Pregnant and nursing women. Currently incarcerated patients.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerstin Bettermann, MD, PhD

Organizational Affiliation

Penn State College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State College of Medicine

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

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