Neuroprotection of Pioglitazone in Acute Ischemic Stroke
Primary Purpose
Stroke
Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Pioglitazone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical Universtiy- Shuang Ho Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pioglitazone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Modified Rankin Scale (mRS)
Secondary Outcome Measures
National Institute of Health Stroke Scale (NIHSS)
Barthel's Index
Full Information
NCT ID
NCT02195791
First Posted
July 14, 2014
Last Updated
January 18, 2017
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02195791
Brief Title
Neuroprotection of Pioglitazone in Acute Ischemic Stroke
Official Title
Mechanism of Hyperglycemia and Neuroprotection Effect of Pioglitazone in Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Diffculty in participant enrollment
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pioglitazone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (oral) 1 tab once daily for 7 days
Primary Outcome Measure Information:
Title
Modified Rankin Scale (mRS)
Time Frame
Day 90 after stroke
Secondary Outcome Measure Information:
Title
National Institute of Health Stroke Scale (NIHSS)
Time Frame
Day 90 after stroke
Title
Barthel's Index
Time Frame
Day 90 after stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Fang Chi, MD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical Universtiy- Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Neuroprotection of Pioglitazone in Acute Ischemic Stroke
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