Neuroprotection of Pioglitazone in Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02195791
• Other study ID #: MOHW103-TDU-B-212-113001 S
• Status: Terminated
• Phase: Phase 2
• First received: July 14, 2014
• Last updated: January 18, 2017
• Start date: July 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Pioglitazone
Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days
• Placebo
Placebo (oral) 1 tab once daily for 7 days

Locations

Country	Name	City	State
Taiwan	Taipei Medical Universtiy- Shuang Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (mRS)		Day 90 after stroke
Secondary	National Institute of Health Stroke Scale (NIHSS)		Day 90 after stroke
Secondary	Barthel's Index		Day 90 after stroke