NCT04123067

Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Pioglitazone 45 mg	45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
DRUG	Placebo oral tablet	placebo daily for three subsequent days, initiated within 12h of stroke symptom onset

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-04-07
• Completion: 2021-04-07
• First posted: 2019-10-10
• Last updated: 2022-09-15
• Results posted: 2022-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study