Neuroprotection of Pioglitazone in Acute Ischemic Stroke

NCT ID: NCT02195791

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pioglitazone

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (oral) 1 tab once daily for 7 days

Interventions

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Pioglitazone

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

Intervention Type DRUG

Placebo

Placebo (oral) 1 tab once daily for 7 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nai-Fang Chi, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical Universtiy- Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MOHW103-TDU-B-212-113001 S

Identifier Type: -

Identifier Source: org_study_id

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