Status:
TERMINATED
Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Stroke, Acute
Hyperglycemia
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
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 int...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04123067
Start Date
September 1 2020
End Date
April 7 2021
Last Update
September 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033