<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/NCT03252626</url>
  </required_header>
  <id_info>
    <org_study_id>SEAAIS</org_study_id>
    <nct_id>NCT03252626</nct_id>
  </id_info>
  <brief_title>Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke</brief_title>
  <official_title>Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ischemic stroke has a variety of treatments and currently drug therapy is one of the main&#xD;
      treatments.A number of clinical studies have proved that alprostadil (PGE1) has&#xD;
      pharmacological effects of significant dilation of blood vessels, inhibition of plate&#xD;
      aggregation, anti-atherosclerosis and increased cerebral blood flow.Evaluate the 90-days&#xD;
      efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mRS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 18, 2022</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Rankin Scale at Day 90</measure>
    <time_frame>day 90</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke</measure>
    <time_frame>day 30, day 90</time_frame>
    <description>Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke</measure>
    <time_frame>day 30, day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index score</measure>
    <time_frame>day 30, day 90</time_frame>
    <description>compared the changes in activities of daily living (Barthel index) between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D scale</measure>
    <time_frame>day 30, day 90</time_frame>
    <description>compared the changes in EQ-5D scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Documentation of adverse events (AEs)</measure>
    <time_frame>day 30, day 90</time_frame>
    <description>compared the rates of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">950</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Alprostadil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Based on the standard medical care, 2ml of Alprostadil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Based on the standard medical care, 2ml of 0.9% saline as the placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprostadil</intervention_name>
    <description>Alprostadil injection USP for intravascular infusion contains 500 micrograms Alprostadil, more commonly known as prostaglandin E1. Vasodilation, inhibition of platelet aggregation are among the most notable of these effects.&#xD;
2ml Alprostadil injection added into 10ml 0.9% saline.</description>
    <arm_group_label>Alprostadil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>2ml normal saline injection added into 10ml 0.9% saline.</description>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ischemic stroke diagnosed by CT or MRI&#xD;
&#xD;
          2. Age: 18-75 years&#xD;
&#xD;
          3. Pre-stroke mRS score is 0-1&#xD;
&#xD;
          4. within 72 hours symptoms onset&#xD;
&#xD;
          5. 4 ≤ NIHSS &lt;20&#xD;
&#xD;
          6. Patient is willing to participate voluntarily and to sign a written patient informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. intracranial tumors, encephalitis or lesions diagnosed by CT or MRI&#xD;
&#xD;
          2. patients with thrombolytic therapy&#xD;
&#xD;
          3. low platelet , blood system diseases or other bleeding tendency&#xD;
&#xD;
          4. suspected subarachnoid hemorrhage or aortic dissection coma&#xD;
&#xD;
          5. atrial fibrillation, myocardial infarction, heart valve disease, infective&#xD;
             endocarditis, heart rate &lt;50 beats / min&#xD;
&#xD;
          6. ALT or AST continued to rise more than 3 times the upper limit of normal creatinine&#xD;
             clearance rate&lt;30ml/min&#xD;
&#xD;
          7. Dementia and mental illness&#xD;
&#xD;
          8. Patient who is participating in other trials or has been participated in other trials&#xD;
             in recent 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</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>Alprostadil</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/NCT03252626
org study id: SEAAIS
nct id: NCT03252626
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Ischemic stroke has a variety of treatments and currently drug therapy is one of the main
      treatments.A number of clinical studies have proved that alprostadil (PGE1) has
      pharmacological effects of significant dilation of blood vessels, inhibition of plate
      aggregation, anti-atherosclerosis and increased cerebral blood flow.Evaluate the 90-days
      efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mRS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Modified Rankin Scale at Day 90
time frame: day 90
measure: Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
time frame: day 30, day 90
description: Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
measure: Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
time frame: day 30, day 90
measure: Barthel Index score
time frame: day 30, day 90
description: compared the changes in activities of daily living (Barthel index) between the two groups
measure: EQ-5D scale
time frame: day 30, day 90
description: compared the changes in EQ-5D scale
measure: Documentation of adverse events (AEs)
time frame: day 30, day 90
description: compared the rates of adverse events
arm group label: Alprostadil
arm group type: Active Comparator
description: Based on the standard medical care, 2ml of Alprostadil
arm group label: Normal saline
arm group type: Placebo Comparator
description: Based on the standard medical care, 2ml of 0.9% saline as the placebo
intervention type: Drug
intervention name: Alprostadil
description: Alprostadil injection USP for intravascular infusion contains 500 micrograms Alprostadil, more commonly known as prostaglandin E1. Vasodilation, inhibition of platelet aggregation are among the most notable of these effects.
2ml Alprostadil injection added into 10ml 0.9% saline.
arm group label: Alprostadil
intervention type: Drug
intervention name: Normal saline
description: 2ml normal saline injection added into 10ml 0.9% saline.
arm group label: Normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Alprostadil