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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
950
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.
2ml normal saline injection added into 10ml 0.9% saline.
Modified Rankin Scale at Day 90
Time frame: day 90
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
Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
Time frame: day 30, day 90
Barthel Index score
compared the changes in activities of daily living (Barthel index) between the two groups
Time frame: day 30, day 90
EQ-5D scale
compared the changes in EQ-5D scale
Time frame: day 30, day 90
Documentation of adverse events (AEs)
compared the rates of adverse events
Time frame: day 30, day 90
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