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Neuroprotection of Pioglitazone in Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02195791
Recruitment Status : Terminated (Diffculty in participant enrollment)
First Posted : July 21, 2014
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Pioglitazone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanism of Hyperglycemia and Neuroprotection Effect of Pioglitazone in Acute Ischemic Stroke
Study Start Date : July 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Active Comparator: Pioglitazone Drug: Pioglitazone
Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days

Placebo Comparator: Placebo Drug: Placebo
Placebo (oral) 1 tab once daily for 7 days




Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: Day 90 after stroke ]

Secondary Outcome Measures :
  1. National Institute of Health Stroke Scale (NIHSS) [ Time Frame: Day 90 after stroke ]
  2. Barthel's Index [ Time Frame: Day 90 after stroke ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195791


Locations
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Taiwan
Taipei Medical Universtiy- Shuang Ho Hospital
New Taipei City, Taiwan, 235
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Principal Investigator: Nai-Fang Chi, MD Taipei Medical University Shuang Ho Hospital

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Responsible Party: Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT02195791     History of Changes
Other Study ID Numbers: MOHW103-TDU-B-212-113001 S
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs