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

Not yet recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Normal Saline Drug
    Intervention Desc: 2ml normal saline injection added into 10ml 0.9% saline.
    ARM 1: Kind: Experimental
    Label: Normal saline
    Description: Based on the standard medical care, 2ml of 0.9% saline as the placebo
  • Alprostadil Drug
    Intervention Desc: 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 1: Kind: Experimental
    Label: Alprostadil
    Description: Based on the standard medical care, 2ml of Alprostadil

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale at Day 90 day 90
Secondary Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke day 30, day 90
Secondary Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke day 30, day 90
Secondary Barthel Index score day 30, day 90
Secondary EQ-5D scale day 30, day 90
Secondary Documentation of adverse events (AEs) day 30, day 90

Sponsors