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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: Alprostadil
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alprostadil<br>Based on the standard medical care, 2ml of Alprostadil | Drug: Alprostadil<br>* 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.<br>|
| Placebo Comparator: Normal saline<br>Based on the standard medical care, 2ml of 0.9% saline as the placebo | Drug: Normal saline<br>* 2ml normal saline injection added into 10ml 0.9% saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale at Day 90 |  | day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day 30, day 90 | 
| Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke |  | day 30, day 90 | 
| Barthel Index score | compared the changes in activities of daily living (Barthel index) between the two groups | day 30, day 90 | 
| EQ-5D scale | compared the changes in EQ-5D scale | day 30, day 90 | 
| Documentation of adverse events (AEs) | compared the rates of adverse events | day 30, day 90 |