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Not yet recruitingNCT03252626Updated Apr 1, 2024

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

A Phase 4 interventional study of Alprostadil and Normal saline in Stroke, sponsored by The First Hospital of Jilin University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by The First Hospital of Jilin University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
950
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
950 participants (estimated)

Study arms

  • Active comparator
    Alprostadil

    Based on the standard medical care, 2ml of Alprostadil

    Drug: Alprostadil

  • Placebo comparator
    Normal saline

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

    Drug: Normal saline

Interventions

  • DrugAlprostadil

    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.

  • DrugNormal saline

    2ml normal saline injection added into 10ml 0.9% saline.

05

What researchers measure

Primary outcomes

  1. Modified Rankin Scale at Day 90

    Time frame: day 90

Secondary outcomes

  1. 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.

    Time frame: day 30, day 90

  2. Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke

    Time frame: day 30, day 90

  3. Barthel Index score

    compared the changes in activities of daily living (Barthel index) between the two groups

    Time frame: day 30, day 90

  4. EQ-5D scale

    compared the changes in EQ-5D scale

    Time frame: day 30, day 90

  5. Documentation of adverse events (AEs)

    compared the rates of adverse events

    Time frame: day 30, day 90

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03252626
Lead sponsor
The First Hospital of Jilin University
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Apr 18, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Apr 1, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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