Neuroprotection of Pioglitazone in Acute Ischemic Stroke

Mechanism of Hyperglycemia and Neuroprotection Effect of Pioglitazone in Acute Ischemic Stroke

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02195791

Enrollment

Registered

2014-07-21

Start date

2014-07-31

Completion date

2016-08-31

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

Pioglitzone, an oral anti-diabetic drug which can reduce insulin resistance and decrease inflammation. It has been proven to be an effective neuroprotective agent in animal model of ischemic stroke. In this study, the investigators will conduct a phase II clinical trial (double-blind, randomized placebo controlled study) to survey the neuroprotection effect of pioglitazone in stroke patients with hyperglycemia. A total of 152 acute ischemic stroke patients with hyperglycemic will receive insulin or sulfonyurea for blood sugar control, and will be randomly randomized into intervention (Pioglitazone 30mg once a day p.o,) and control group (placebo). The investigators expect to prove the neuroprotective efficacy of Pioglitazone in acute stroke with hyperglycemia and identify the biomarkers associated with good neurological outcome in patients with Pioglitazone treatment from the investigators clinical trial.

Interventions

DRUGPioglitazone

Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days

DRUGPlacebo

Placebo (oral) 1 tab once daily for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Acute ischemic stroke onset within 48 hours 2. Age≧20 years 3. Stroke severity with at least one point for limb weakness in National Institutes of Health Stroke Scale (NIHSS). 4. The patients with no known history of diabetes with admission serum glucose ≧130 mg/dl.

Exclusion criteria

1. The patients who have history of urinary bladder cancer or hematuira. 2. The patients who have history of congestive heart failure or myocardial infarction. 3. The patients who have known history of using pioglitazone before the onset of stroke. 4. The patients who have mRS≧3 before stroke onset.

Design outcomes

Primary

Measure	Time frame
Modified Rankin Scale (mRS)	Day 90 after stroke

Secondary

Measure	Time frame
National Institute of Health Stroke Scale (NIHSS)	Day 90 after stroke
Barthel's Index	Day 90 after stroke

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026