Stroke
Conditions
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.
Interventions
DRUGAlprostadil
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.
DRUGNormal saline
2ml normal saline injection added into 10ml 0.9% saline.
Sponsors
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale at Day 90 | day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke | day 30, day 90 | — |
| Barthel Index score | day 30, day 90 | compared the changes in activities of daily living (Barthel index) between the two groups |
| EQ-5D scale | day 30, day 90 | compared the changes in EQ-5D scale |
| Documentation of adverse events (AEs) | day 30, day 90 | compared the rates of adverse events |
Outcome results
None listed