Neuroprotection of Pioglitazone in Acute Ischemic Stroke

NCT02195791 | Terminated Phase 2

• 1 other identifier: MOHW103-TDU-B-212-113001 S
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  Day 90 after stroke

Secondary Outcomes (2)

• National Institute of Health Stroke Scale (NIHSS)

  Day 90 after stroke

• Barthel's Index

  Day 90 after stroke

Study Arms (2)

Pioglitazone

ACTIVE COMPARATOR

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pioglitazone DRUG

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

Pioglitazone

Placebo DRUG

Placebo (oral) 1 tab once daily for 7 days

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical Universtiy- Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nai-Fang Chi, MD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

TW (1)