Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke

NCT04123067 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 00011042
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Hyperglycemia; Diabetes

Outcome Measures

Primary Outcomes (2)

• Neurological Status

  NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score

  90 days post stroke

• Degree of Disability or Dependence in the Daily Activities

  Measured using the modified Rankin Scale (0-6) to assess neurological function with a score of 0 for no neurological deficits and a maximum of 6 for an expired patient

  90 days post stroke

Secondary Outcomes (2)

• Concentration of Markers of Neutrophil Activation and Function

  24 hours, 48 hours, and 90 days post-stroke

• Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine

  24 hours, 48 hours, and 90 days poststroke

Study Arms (2)

Pioglitazone treatment group

EXPERIMENTAL

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

Drug: Pioglitazone 45 mg

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

Pioglitazone 45 mg DRUG

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

Pioglitazone treatment group

Placebo oral tablet DRUG

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

Placebo group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Stroke; Hyperglycemia; Diabetes Mellitus

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study was terminated early due to lack of funding and Responsible Party relocating to another institution

Results Point of Contact

• Title: Dr. Kerstin Bettermann
• Organization: Penn State Hershey Medical Center

kbettermann@pennstatehealth.psu.edu

717-531-1803

Study Officials

• Kerstin Bettermann, MD, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: September 1, 2020
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: September 15, 2022
• Results First Posted: September 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)