search
Back to results

Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alprostadil
Normal saline
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ischemic stroke diagnosed by CT or MRI
  2. Age: 18-75 years
  3. Pre-stroke mRS score is 0-1
  4. within 72 hours symptoms onset
  5. 4 ≤ NIHSS <20
  6. Patient is willing to participate voluntarily and to sign a written patient informed consent

Exclusion Criteria:

  1. intracranial tumors, encephalitis or lesions diagnosed by CT or MRI
  2. patients with thrombolytic therapy
  3. low platelet , blood system diseases or other bleeding tendency
  4. suspected subarachnoid hemorrhage or aortic dissection coma
  5. atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate <50 beats / min
  6. ALT or AST continued to rise more than 3 times the upper limit of normal creatinine clearance rate<30ml/min
  7. Dementia and mental illness
  8. Patient who is participating in other trials or has been participated in other trials in recent 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Alprostadil

    Normal saline

    Arm Description

    Based on the standard medical care, 2ml of Alprostadil

    Based on the standard medical care, 2ml of 0.9% saline as the placebo

    Outcomes

    Primary Outcome Measures

    Modified Rankin Scale at Day 90

    Secondary Outcome Measures

    Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
    Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
    Barthel Index score
    compared the changes in activities of daily living (Barthel index) between the two groups
    EQ-5D scale
    compared the changes in EQ-5D scale
    Documentation of adverse events (AEs)
    compared the rates of adverse events

    Full Information

    First Posted
    August 8, 2017
    Last Updated
    October 12, 2021
    Sponsor
    The First Hospital of Jilin University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03252626
    Brief Title
    Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
    Official Title
    Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 18, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    950 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Alprostadil
    Arm Type
    Active Comparator
    Arm Description
    Based on the standard medical care, 2ml of Alprostadil
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Based on the standard medical care, 2ml of 0.9% saline as the placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Alprostadil
    Intervention 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Intervention Description
    2ml normal saline injection added into 10ml 0.9% saline.
    Primary Outcome Measure Information:
    Title
    Modified Rankin Scale at Day 90
    Time Frame
    day 90
    Secondary Outcome Measure Information:
    Title
    Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
    Description
    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
    Time Frame
    day 30, day 90
    Title
    Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
    Time Frame
    day 30, day 90
    Title
    Barthel Index score
    Description
    compared the changes in activities of daily living (Barthel index) between the two groups
    Time Frame
    day 30, day 90
    Title
    EQ-5D scale
    Description
    compared the changes in EQ-5D scale
    Time Frame
    day 30, day 90
    Title
    Documentation of adverse events (AEs)
    Description
    compared the rates of adverse events
    Time Frame
    day 30, day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ischemic stroke diagnosed by CT or MRI Age: 18-75 years Pre-stroke mRS score is 0-1 within 72 hours symptoms onset 4 ≤ NIHSS <20 Patient is willing to participate voluntarily and to sign a written patient informed consent Exclusion Criteria: intracranial tumors, encephalitis or lesions diagnosed by CT or MRI patients with thrombolytic therapy low platelet , blood system diseases or other bleeding tendency suspected subarachnoid hemorrhage or aortic dissection coma atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate <50 beats / min ALT or AST continued to rise more than 3 times the upper limit of normal creatinine clearance rate<30ml/min Dementia and mental illness Patient who is participating in other trials or has been participated in other trials in recent 3 months

    12. IPD Sharing Statement

    Learn more about this trial

    Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke

    We'll reach out to this number within 24 hrs