<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02195791</url>
  </required_header>
  <id_info>
    <org_study_id>MOHW103-TDU-B-212-113001 S</org_study_id>
    <nct_id>NCT02195791</nct_id>
  </id_info>
  <brief_title>Neuroprotection of Pioglitazone in Acute Ischemic Stroke</brief_title>
  <official_title>Mechanism of Hyperglycemia and Neuroprotection Effect of Pioglitazone in Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Shuang Ho Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University Shuang Ho Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pioglitzone, an oral anti-diabetic drug which can reduce insulin resistance and decrease&#xD;
      inflammation. It has been proven to be an effective neuroprotective agent in animal model of&#xD;
      ischemic stroke. In this study, the investigators will conduct a phase II clinical trial&#xD;
      (double-blind, randomized placebo controlled study) to survey the neuroprotection effect of&#xD;
      pioglitazone in stroke patients with hyperglycemia. A total of 152 acute ischemic stroke&#xD;
      patients with hyperglycemic will receive insulin or sulfonyurea for blood sugar control, and&#xD;
      will be randomly randomized into intervention (Pioglitazone 30mg once a day p.o,) and control&#xD;
      group (placebo). The investigators expect to prove the neuroprotective efficacy of&#xD;
      Pioglitazone in acute stroke with hyperglycemia and identify the biomarkers associated with&#xD;
      good neurological outcome in patients with Pioglitazone treatment from the investigators&#xD;
      clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Diffculty in participant enrollment&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Rankin Scale (mRS)</measure>
    <time_frame>Day 90 after stroke</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health Stroke Scale (NIHSS)</measure>
    <time_frame>Day 90 after stroke</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel's Index</measure>
    <time_frame>Day 90 after stroke</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Pioglitazone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pioglitazone</intervention_name>
    <description>Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days</description>
    <arm_group_label>Pioglitazone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (oral) 1 tab once daily for 7 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute ischemic stroke onset within 48 hours&#xD;
&#xD;
          2. Age≧20 years&#xD;
&#xD;
          3. Stroke severity with at least one point for limb weakness in National Institutes of&#xD;
             Health Stroke Scale (NIHSS).&#xD;
&#xD;
          4. The patients with no known history of diabetes with admission serum glucose ≧130&#xD;
             mg/dl.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients who have history of urinary bladder cancer or hematuira.&#xD;
&#xD;
          2. The patients who have history of congestive heart failure or myocardial infarction.&#xD;
&#xD;
          3. The patients who have known history of using pioglitazone before the onset of stroke.&#xD;
&#xD;
          4. The patients who have mRS≧3 before stroke onset.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nai-Fang Chi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University Shuang Ho Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Medical Universtiy- Shuang Ho Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>235</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pioglitazone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02195791
org study id: MOHW103-TDU-B-212-113001 S
nct id: NCT02195791
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Modified Rankin Scale (mRS)
time frame: Day 90 after stroke
measure: National Institute of Health Stroke Scale (NIHSS)
time frame: Day 90 after stroke
measure: Barthel's Index
time frame: Day 90 after stroke
arm group label: Pioglitazone
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Pioglitazone
description: Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days
arm group label: Pioglitazone
intervention type: Drug
intervention name: Placebo
description: Placebo (oral) 1 tab once daily for 7 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Nai-Fang Chi, MD
role: Principal Investigator
affiliation: Taipei Medical University Shuang Ho Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Pioglitazone