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

Sponsor
The First Hospital of Jilin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03252626
Collaborator
(none)
950
2
10.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
950 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
Anticipated Study Start Date :
Aug 18, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Alprostadil

Based on the standard medical care, 2ml of Alprostadil

Drug: Alprostadil
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.

Placebo Comparator: Normal saline

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

Drug: Normal saline
2ml normal saline injection added into 10ml 0.9% saline.

Outcome Measures

Primary Outcome Measures

  1. Modified Rankin Scale at Day 90 [day 90]

Secondary Outcome Measures

  1. Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke [day 30, day 90]

    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.

  2. Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke [day 30, day 90]

  3. Barthel Index score [day 30, day 90]

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

  4. EQ-5D scale [day 30, day 90]

    compared the changes in EQ-5D scale

  5. Documentation of adverse events (AEs) [day 30, day 90]

    compared the rates of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:
  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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT03252626
Other Study ID Numbers:
  • SEAAIS
First Posted:
Aug 17, 2017
Last Update Posted:
Oct 14, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021