Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

Penn State Health

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Diabetes; Hyperglycemia; Stroke, Acute

Treatments: Drug: Pioglitazone 45 mg; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04123067

00011042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Pioglitazone treatment group

Experimental group

Description:

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

Treatment:

Drug: Pioglitazone 45 mg

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet