- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02195791
Neuroprotection of Pioglitazone in Acute Ischemic Stroke
January 18, 2017 updated by: Taipei Medical University Shuang Ho Hospital
Mechanism of Hyperglycemia and Neuroprotection Effect of Pioglitazone in Acute Ischemic Stroke
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
New Taipei City, Taiwan, 235
- Taipei Medical Universtiy- Shuang Ho Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute ischemic stroke onset within 48 hours
- Age≧20 years
- Stroke severity with at least one point for limb weakness in National Institutes of Health Stroke Scale (NIHSS).
- The patients with no known history of diabetes with admission serum glucose ≧130 mg/dl.
Exclusion Criteria:
- The patients who have history of urinary bladder cancer or hematuira.
- The patients who have history of congestive heart failure or myocardial infarction.
- The patients who have known history of using pioglitazone before the onset of stroke.
- The patients who have mRS≧3 before stroke onset.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo (oral) 1 tab once daily for 7 days
|
Active Comparator: Pioglitazone
|
Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modified Rankin Scale (mRS)
Time Frame: Day 90 after stroke
|
Day 90 after stroke
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
National Institute of Health Stroke Scale (NIHSS)
Time Frame: Day 90 after stroke
|
Day 90 after stroke
|
Barthel's Index
Time Frame: Day 90 after stroke
|
Day 90 after stroke
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nai-Fang Chi, MD, Taipei Medical University Shuang Ho Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
July 14, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 21, 2014
Study Record Updates
Last Update Posted (Estimate)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOHW103-TDU-B-212-113001 S
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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