Neuroprotection of Pioglitazone in Acute Ischemic Stroke

Phase 2

Terminated

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Pioglitazone

• Registration Number: NCT02195791
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-21
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pioglitazone	Pioglitazone	-

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	Day 90 after stroke

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Medical Universtiy- Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan