Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Stroke, Acute, Hyperglycemia, Diabetes

In brief

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.

Key facts

Study ID

NCT04123067

Run by

Milton S. Hershey Medical Center

People needed

1

Starts

2020-09-01

Expected to finish

2021-04-07

Last updated by the study team

2022-09-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Penn State College of Medicine — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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