Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

NCT ID: NCT04123067

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-04-07

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.

Conditions

Stroke, Acute; Hyperglycemia; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pioglitazone treatment group

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

Group Type: EXPERIMENTAL

Pioglitazone 45 mg

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

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

Interventions

Pioglitazone 45 mg

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

Intervention Type: DRUG

Placebo oral tablet

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Stroke Patients ages 21 and over

2. Blood sugar ≥ 150 mg/dl

3. 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)

4. MRI or CT proven ischemic stroke

5. Initial NIH SS of ≥ 2

6. Willing and able to provide consent

Exclusion Criteria

1. Known hypersensitivity to PGZ.

2. 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.

3. Active malignancy and / or autoimmune disease requiring treatment.

4. Use of immunomodulatory drugs or chemotherapy.

5. History of stroke or brain injury within the last 90 days prior to presentation.

6. Acute illness within the last 30 days which could have affected the white blood cell count.

7. Known history of clinically significant hypoglycemia.

8. Patients already taking PGZ.

9. Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin > 1.2 mg/dl).

10. 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.

11. History of bladder cancer

12. Pregnant and nursing women.

13. Currently incarcerated patients.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerstin Bettermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State College of Medicine

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00011042

Identifier Type: -

Identifier Source: org_study_id