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

NCT03252626 — Phase 4, Unknown, 950 participants, The First Hospital of Jilin University

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Registry	NCT03252626
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	950 (Estimated)
Sponsor	The First Hospital of Jilin University (Other)
Conditions	Stroke
Interventions	Alprostadil, Normal saline (Drug)
Dates	start 2024-04-18 (estimated), primary completion 2024-12-31 (estimated), completion 2025-06-30 (estimated), first posted 2017-08-17, last updated 2024-04-01

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Alprostadil	Active comparator	Drug: Alprostadil	Based on the standard medical care, 2ml of Alprostadil
Normal saline	Placebo comparator	Drug: Normal saline	Based on the standard medical care, 2ml of 0.9% saline as the placebo

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.
Normal saline (Drug): 2ml normal saline injection added into 10ml 0.9% saline.

+Outcome measures

Primary outcomes

Modified Rankin Scale at Day 90 [day 90]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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