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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprostadil | Active Comparator | Based on the standard medical care, 2ml of Alprostadil |
|
| Normal saline | Placebo Comparator | Based on the standard medical care, 2ml of 0.9% saline as the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprostadil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale at Day 90 | day 90 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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|
| Normal saline | Drug | 2ml normal saline injection added into 10ml 0.9% saline. |
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |