Stroke, AcutePhase 1/2NCT04123067
Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke
A Phase 1/2 study testing Pioglitazone 45 mg in people with Stroke, Acute and Hyperglycemia, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Acute, Hyperglycemia, Diabetes
- What is being tested?
- Pioglitazone 45 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 7 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response
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.
Read the 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
- Being tested
- Pioglitazone 45 mg, Placebo oral tablet
- Medical subject headings
- Stroke, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone 45 mgDrug
45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
Placebo oral tabletDrug
placebo daily for three subsequent days, initiated within 12h of stroke symptom onset
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone treatment group | Experimental | oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset Receives: Drug: Pioglitazone 45 mg |
| Placebo group | Placebo comparator | Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Status
NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score
Measured: 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
Measured: 90 days post stroke
Secondary outcomes (2)
Concentration of Markers of Neutrophil Activation and Function
measured in blood by flow cytometry
Measured: 24 hours, 48 hours, and 90 days post-stroke
Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine
measured in blood
Measured: 24 hours, 48 hours, and 90 days poststroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Sep 2020
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Why it stopped: Temporarily suspended due to Pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerstin Bettermann, MD, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123067
- Sponsor's protocol ID
- 00011042
- Status last verified
- Aug 2022
- First submitted
- 8 Oct 2019
- Last updated
- 15 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response
- ClinicalTrials.gov ID
- NCT04123067
- Acronym / sponsor ID
- 00011042
- Conditions
- Stroke, Acute, Hyperglycemia, Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Temporarily suspended due to Pandemic.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 15 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone treatment group | Experimental | Drug: Pioglitazone 45 mgoral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset |
| Placebo group | Placebo comparator | Drug: Placebo oral tabletOral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone 45 mg45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset | Drug | Pioglitazone treatment group |
| Placebo oral tabletplacebo daily for three subsequent days, initiated within 12h of stroke symptom onset | Drug | Placebo group |
Primary outcome
Neurological Status
Time frame: 90 days post stroke
NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score
Degree of Disability or Dependence in the Daily Activities
Time frame: 90 days post stroke
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
2 secondary outcomes
Concentration of Markers of Neutrophil Activation and Function
Time frame: 24 hours, 48 hours, and 90 days post-stroke
Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine
Time frame: 24 hours, 48 hours, and 90 days poststroke
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin Bettermann, MD, PhD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pioglitazone 45 mg in people with Stroke, Acute and Hyperglycemia, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Status (time frame: 90 days post stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.